Free Redacted Document - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE SIEMENS MEDICAL SOLUTIONS USA, INC., Plaintiff, v. SAINT-GOBAIN CERAMICS & PLASTICS, INC., Defendant. ) ) ) ) ) ) ) ) ) ) )

C.A. No. 07-190 (SLR) REDACTED ­ PUBLIC VERSION

AFFIDAVIT OF CHARANJIT BRAHMA MORRIS, NICHOLS, ARSHT & TUNNELL LLP Jack B. Blumenfeld (#1014) Maryellen Noreika (#3208) 1201 North Market Street P.O. Box 1347 Wilmington, Delaware 19899-1347 (302) 658-9200 [email protected] Attorneys for Plaintiff Siemens Medical Solutions USA, Inc. OF COUNSEL: Gregg F. LoCascio Charanjit Brahma Sean M. McEldowney KIRKLAND & ELLIS LLP 655 Fifteenth St., N.W., Suite 1200 Washington, D.C. 20005 (202) 879-5000 Originally Filed: July 9, 2007 Redacted Version Filed: July 20, 2007

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CERTIFICATE OF SERVICE I, the undersigned, hereby certify that on July 20, 2007, I electronically filed the foregoing with the Clerk of the Court using CM/ECF, which will send notification of such filing(s) to the following: Jesse A. Finkelstein, Esquire Jeffrey L. Moyer, Esquire Kelly E. Farnan, Esquire Richards, Layton & Finger, P.A. I also certify that copies were caused to be served on July 20, 2007 upon the following in the manner indicated: BY ELECTRONIC MAIL Jesse A. Finkelstein, Esquire Jeffrey L. Moyer, Esquire Kelly E. Farnan, Esquire Richards, Layton & Finger, P.A. One Rodney Square Wilmington, DE 19801 BY ELECTRONIC MAIL Frederick L. Whitmer, Esquire Thelen Reid Brown Raysman & Steiner LLP 875 Third Avenue New York, NY 10022

/s/ Maryellen Noreika Maryellen Noreika (#3208)

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EXHIBIT 1

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EXHIBIT 4

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EXHIBIT 5

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EXHIBIT 8

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GEMINI TF
The First Commercial Time-of-Flight PET System

2006 IEEE Medical Imaging Conference

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New PET/CT Design Challenges
Image Quality & Applications · Significant improvement in image quality
­ How can you improve my diagnostic confidence? What is the smallest lesion I can see? How consistent is image quality?

· Support of all clinical applications
­ Can I use the scanner for Oncology, Cardiology and Neurology applications? ­ Can I research new Molecular Imaging tracers?
Small lesion detectability

· Is the technology easy to use?
­ Will the system be reliable, stable and user friendly? ­ Does the technology support clinical workflow requirements?
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New PET/CT Design Challenges
Inconsistent image quality between patients of different sizes
Small Patient Large Patient

This is a documented issue with all PET systems: · For an equivalent data signal to noise ratio, a 120 kg person would have to
be scanned 2.3 times longer than a 60 kg person · 5 min/bed position scans are sufficient for optimal lesion detection with LSO PET/CT in obese patients
Optimizing Injected Dose in Clinical PET by Accurately Modeling the Counting-Rate Response Functions Specific to Individual Patient Scans. Charles C. Watson, PhD et al Siemens Medical Solutions Molecular Imaging, Knoxville, Tennessee, JNM Vol. 46 No. 11 1825-1834, 2005 Optimizing Imaging Protocols for Overweight and Obese Patients: A Lutetium Orthosilicate PET/CT Study, Benjamin S. Halpern, et al, UCLA David Geffen School of Medicine, Los Angeles, California, JNM Vol. 46 No. 4 603-607, 2005 3

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PET/CT Design Challenges
Cardiology & Molecular Imaging Cardiology*
· Low statistics - EKG gated imaging · Low statistics - Kinetic modeling (N-13 ammonia)

* - Crump Institute for Molecular Imaging UCLA School of Medicine

Molecular Imaging Applications
· Low statistics ­ dynamic imaging · Low statistics ­ specific isotopes, low dose isotopes
External marker

40 s ec

14 min
FMISO-PET for hypoxia imaging

240 min
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Time-of-Flight
Basic Concept

Coincidence and backprojection

Timing within coincidence window
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Time-of-Flight vs. Conventional PET
Better information sent to reconstruction

Conventional PET Image Formation

Time-of-Flight Image Formation

More precise localization of annihilation event improves image quality
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Time-of-Flight
Effect of System Timing Resolution

Conventional PET Image Formation

1 ns ToF Image Formation

TruFlight (~650 ps) Image Formation

System timing resolution defines performance benefit of time-of-flight
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Time-of-Flight
TruFlight Imaging Benefits

Data courtesy of J Karp, University of Pennsylvania

3D RAMLA

Line of Response

Time-of-Flight

Time-of-flight improves image quality

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Quantifying Image Quality Benefits
Sensitivity Gain[1]
Sensitivity Gain = Object (Patient) Size / ToF Positioning Accuracy ToF Positioning Accuracy = c x Timing Resolution / 2 c = Speed of Light Effective NECR = NECR_0 x Sensitivity Gain NECR_0 = Conventional (NEMA) NECR Effective NECR = Time of Flight NECR TruFlight ­ sensitivity gain ~ 2x - 4x ­ positioning accuracy <10 cm

TruFlight Timing Resolution ~650 ps

[1] Budinger TF. Time-of-Flight Positron Emission Tomography: Status Relative to Conventional PET. J Nucl Med 24(1):73-78, 1983.
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Imaging Challenge
Patient Body Size*
Histogram of the patient body diameter for 65 randomly selected patients Average patient diameter = 27 cm Large patient diameter = 35 cm

* A Quantitative Approach to a Weight-Based Scanning Protocol for PET Oncology Imaging. Paul Kinahan, Phillip Cheng, Adam Alessio, Tom Lewellen, University of Washington, Seattle. Presented at MIC conference 2005. Data used with authors permission.

Dutch clinics under strain from obese patients
Wed Jan 18, 2006 5:11 PM GMT

AMSTERDAM (Reuters) - Dutch hospital beds and operating tables could buckle under the strain of obese patients, doctors have complained, adding some patients barely fit into scanning machines.
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TruFlight Technology
Benefits increase with the size of the patient Sensitivity Gain = Object (Patient) Size / ToF Positioning Accuracy
Small Patient Average Patient Large Patient

1

2 2.5

1

2 3

1

2

3

4

Sensitivity Gain = 2.5X

Sensitivity Gain > 3 X

Sensitivity Gain = 4.0 X

· Time of flight reduces noise resulting in higher image quality, shorter scans or lower dose · Image quality improvement is higher in large patients resulting in consistent image quality across patients
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GEMINI TF Technology

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Philips PET
TruFlight

TruFlight
Scintillator Detector PMTs
Timing & Uniformity

Electronics
Speed, accuracy & calibration

Recon

Stopping Power Resolution, light & Timing Resolution collection, & encoding

Algorithm design & processing speed

All aspects of system design must be optimized for Time-of-Flight Imaging

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TruFlight
Scintillator ­ Stopping Power & Timing Resolution

Scintillator

Property Density Effective Z Attenuation length Energy Resolution Light Yield Decay Time Timing Resolution (two crystals in coincidence)

LSO
7.4 66 1.15 ~11% 1.0 ~40 ns

LYSO
7.1 (10% Y) 64 1.2 ~10% 1.2 ~40 ns

GSO
6.7 57 1.4 ~10% <0.5 60 ns Not optimal performance for time of flight

BGO
7.1 75 1.04 >13% <0.2 300 ns

LuAP
8.3 66 1.04 7-9% ~0.5 17 ns

LaBr3
5.3 47 2.1 3% 2.0 35 ns

~450 ps

<450 ps

Not suitable for ToF

500ps

<400ps

LYSO selected because of timing resolution, stopping power & availability

The rest of the system design must maintain as much of this intrinsic timing resolution as possible!
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TruFlight
Detector ­ Resolution, light collection, & encoding

Detector

1. With ToF, small crystal size (4x4x22mm) AND exceptional sensitivity 2. Preserve intrinsic energy resolution with PIXELAR detector design
PMT

PMT

...

7 6

2 1 5

3 4

...

Conventional Block Detector
· Optically isolated from surrounding blocks · 4 PMTs used to localize · Light collection dropoff at edges of blocks · Light collection variability with position

Philips PIXELAR Detector
· Panels connected optically via continuous lightguide · 5-7 PMTs used to localize, better identification · Light collection dropoff only at edge of FOV · Small light collection variability

Results: Energy Resolution of 12% and 30% Scatter Fraction
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TruFlight
PMTs ­ Timing and Uniformity · PMT choice critical to timing resolution & stability · Conventional PMTs are not suitable for ToF imaging
­ flat cathode delivers non-uniform timing response ­ unacceptable loss in timing resolution

PMTs

· Uniformity of timing response across tube ( = among crystals) is critical to preserve system timing resolution, requires curved cathode

Conventional (flat) PMT

TruFlight PMT (curved) PMT
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TruFlight
Electronics ­ Speed & Accuracy
Designed for Timing Accuracy
TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT TOF PMT

Electronics

TIME OF FLIGHT FRONT END * GAIN NORMALIZATION * TRANSIT TIME NORMALIZATION * ENERGY SHAPING *TOF TRIGGERING

TIME OF FLIGHT FRONT END * GAIN NORMALIZATION * TRANSIT TIME NORMALIZATION * ENERGY SHAPING *TOF TRIGGERING

TIME OF FLIGHT FRONT END * GAIN NORMALIZATION * TRANSIT TIME NORMALIZATION * ENERGY SHAPING *TOF TRIGGERING

TIME OF FLIGHT FRONT END * GAIN NORMALIZATION * TRANSIT TIME NORMALIZATION * ENERGY SHAPING *TOF TRIGGERING

ENERGY SIGNALS 1 per PMT

TRIGGER SIGNALS 1 per 15 PMTs

PHILIPS PET IMAGING SYSTEM DATA ACQUISITION BLOCK DIAGRAM

text text ENERGY DIGITIZERS text *100 Msps 10 Bit *DIGITAL INTEGRATORS

MASTER CONTROL AND TIMING *35 psec TIMESTAMPER

PPU Position Processing Unit

CRB Corrections and Rebinning

LISTMODE DATA ACQUISITION

· 25 psec time stamp for accurate data sampling · ToF Timing Resolution ­ 650 psec · Crystal 450 psec · PMTs 100 psec · Other 100 psec ­ electronics design plays a key role in preserving the timing resolution

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TruFlight
Electronics ­ Calibration · Historical (1980s) research systems
­ timing stability measured in minutes ­ recalibration measured in hours

Electronics

· Clinical requirement: stable time response for days & easy and fast recalibration · GEMINI TF designed for ~5 minute (daily) automated timing calibration (standard Na-22 source) and consistent performance
Timing Resolution (FWHM) vs. Time

Graph depicts system timing resolution measured daily on a system in clinical usage at the Hospital of the University of Pennsylvania

Dec-05

Feb-06
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TruFlight
Reconstruction ­ Algorithm Design · · · Technical challenge: acceptable reconstruction times with an extremely large data set (~10x compared to LOR) Enhancements in available computing power are one of the key enablers of clinically useful ToF imaging New TruFlight Reconstruction Algorithm

Recon

­ Event-by-event reconstruction requires list mode acquisition & processing ­ Based on RAMLA / Blob & LOR ­ Now incorporates relative timing information

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TruFlight
Reconstruction ­ Processing Speed

Recon

TruFlight reconstruction architecture converts a very large task (~10x compared LOR recon) into multiple smaller tasks to then distributes it to more computers (CIRS)
computer 1 computer 2 copy Prj g1 Prj g2 Prj gn computer n copy

H

Obj f

H

Obj f

H

Obj f

Multi-processor dedicated reconstruction Computer

Corr(g1, Hf)

Corr(g2, Hf)

......

Corr(gn , Hf)

HT
+

HT

HT

update

Distribution of the projection data among multiple processors results in a clinically practical reconstruction time

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TruFlight
Strategic Design over Time

TruFlight
Scintillator Detector PMTs
Timing & Uniformity

Electronics
Speed, accuracy & calibration

Recon

Stopping Power Resolution, light & Timing Resolution collection, & encoding

Algorithm design & processing speed

· ToF imaging cannot be simply "added" to a conventional system · Philips has been developing the building blocks for many years
Key Time-of-Flight Enabler
Pixelar detector design 3D RAMLA Reconstruction List mode acquisition LOR ("crystal space" processing) CIRS distributed processing architecture Time-stamping electronics architecture Allegro Allegro GEMINI GEMINI GXL GEMINI GXL GEMINI GXL
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Philips Product

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GEMINI TF Clinical Results

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78 kg 171 lbs 12 mCi <15 min acquisition

GEMINI TF Performance
Image Quality

Images courtesy of University Hospitals of Cleveland

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GEMINI TF Performance
8.5 mCi 19 min acquisition Comments Image Quality

Images courtesy of Montefiore Medical Center

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GEMINI TF Performance
Image Quality Arms Down 9.2 mCi 19 min acquisition

Images courtesy of Montefiore Medical Center

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103 kg 227 lbs 12.3 mCi <15 min acquisition

GEMINI TF Performance
Image Quality

Images courtesy of University Hospitals of Cleveland

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GEMINI TF Performance
141 kg 310 lbs 10.5 mCi 19 min acquisition Image Quality

Images courtesy of Montefiore Medical Center

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GEMINI TF Performance
<15 min acquisition Image Quality

Images courtesy of University Hospitals of Cleveland

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GEMINI TF Performance
Image Quality

Aorta 68 kg 150 lbs 10.3 mCi <15 min acquisition

Images courtesy of University Hospitals of Cleveland

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GEMINI TF Performance
Neurology Image Quality

10 mCi 10 min PET Acquisition

Images courtesy of University Hospitals of Cleveland

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GEMINI TF Performance
74 kg 163 lbs 1min mCi 9.5 Fast Acquisition (<10 Minute PET Acquisition)

Images courtesy of Montefiore Medical Center

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GEMINI TF Performance
Fast Acquisition (<10 Minute PET Acquisition) 76 kg 167 lbs 11.3 mCi

Images courtesy of Montefiore Medical Center

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GEMINI TF
Oncology · · Visualize smaller lesions through improved image accuracy and higher sensitivity. Consistent image quality in large patients.
Small Patient Large Patient Small Patient Large Patient

Conventional PET

GEMINI TF

TruFlight < 10 min whole body PET for every body

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GEMINI TF
TruFlight Technology

Perfect for every body.

Unquestionably unequivocal
· Extracting the true benefits of time-of-flight technology - Improved image quality, lesion detectability and patient throughput · Creating the new benchmark in consistent image quality · Opening the pathway to molecular imaging applications

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GEMINI TF PET/CT.
The new benchmark in speed, comfort, clarity and flexibility.

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EXHIBIT 9

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OCT 7 - 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS General Information A. Submitteri Contact Person: Philips Medical Systems (Cleveland), Inc. 595 Miner Rd. Cleveland, OH 44143 Melinda Novatny Tel: (440) 483-4255 Fax: (440) 483-7339

B.

Device Trade Name: Gemini Raptor Common Name: Positron Emission Tomography Computed Tomography X-Ray Classification Name: System, Emission Computed Tomography, (892.1200) System, Computed Tomography X-Ray, (892.1750) Device Class: 21CFR 892.1200, Class 1I 21 CFR 892.1750, Class II Product Code: 90 KPS and 90 JAK Classification Panel: Radiology

C. D. E.

Date prepared: Predicate Device:

September 15, 2005 Gemini GXL System (KO51170)

Performance Standards: * 21 CFR 1020.30 - 1020.33 Performance Standards for Ionizing Radiation Emitting Products, Computed Tomography Equipment (Applicable Sections) * NEMA NU-2 Intended Use: The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:

F.

Section X.-1

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o The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. o The detection, localization, and staging of tumors and diagnosing cancer patients. o Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of with regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. G. Device Description! Comparison with Predicate Device: The device is a hybrid diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanners that can be utilized in fixed installations or mobile environments. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET), X-ray Computed Tomography (CT), a patient table, gantry separation unit, and the acquisition and processing workstations. System Performance Test/Summary of Studies: To minimize electrical, mechanical and radiation hazards, Philips Medical System adheres to recognized and established industry practice. Radiation safety is assured by compliance and certification to the performance standards for ionizing radiation emitting product, 21CFR 1020.30 and 21CFR 1020.33. The radiation safety product report will be filed in accordance with 21CFR 1002.10 with the Center for Device and Radiological Health. Electrical and mechanical safety is assured by adherence and certification to the applicable standards in the IEC 60601-1 series. The device performance was measured in accordance with the NEMA-NU2 standard. Comparison to Predicate Devices: The basic differences in the system include the following: · * Change from GSO to LYSO crystals Modifications to Reconstruction

H.

I.

In conclusion, the device is substantially equivalent to the predicate devices based upon similar intended use, technological comparison, and system performance. Section X.-2

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

OCT 7 - 2885

Food and Drug Administration 9200 Corporate Boulevard

Rockville MD 20850

Philips Medical Systems (Cleveland), Inc. % Ms. Elizabeth Drew Project Engineer, Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Re: K052640 Trade/Device Name: GEMINI Raptor Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: September 21, 2005 Received: September 26, 2005

Dear Ms. Drew: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: 21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxx Other (Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology) 240-276-0115 240-276-0115 240-276-0120 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours,

1'z/7ayn &{Je 4C,h~jt
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure

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Indications for Use
510(k) Number (if known): N,,.-'ozDevice Name: Gemini Raptor Indications for Usa
The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces crosssectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: o The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. o The detection, localization, and staging of tumors and diagnosing cancer patients. o Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of leftventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.

_

Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

Prescription Use V1 (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page )of
(Division Sign-OfMf/ 610(k)Number
Division of Reproductive. Abdomin and Radiological Devices

t

-

:

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Philips showcases clinical results of time-of-flight imaging for PET/CT
Health Imaging News | June 7, 2006 | SNM 360 Philips Medical Systems this week revealed clinical results from its Gemini TF (Time of Flight) PET/CT system and introduced an enhanced JETStream Workspace version 3.0 which offers new workflow and image display enhancements, new image analysis tools, as well as upgrades in clinical applications such as cardiac, bone, renal, salivary and brain. GEMINI TF features time of flight PET imaging, which Philips calls TruFlight. Regardless of patient size, the system is designed to improve image quality, consistency and performance with low count-rate imaging, according to Philips. It enables small lesion detectability and permits higher patient throughput thanks to a reduction in noise resulting in higher image quality, shorter scans or lower dose. Three units are in field tests ­ one at the the Hospital of the University of Pennsylvania conducting research on four to five patients daily; one at University Hospitals in Cleveland imaging seven to eight patients a day and focused on clinical work; and one at Montefiore focused on quick image acquisitions that images about 15 patients per day, Philips said. Full commercial release of the system is slated for late this month. The enhanced version of the JETStream Workspace version 3.0 offers new workflow and image display enhancements and upgraded clinical applications. It also now includes IDL ­ the programming language for data visualization and analysis developed by RSI ­ that is now available on the workspace. It allows customers to develop and customize their own applications. All in all, JETStream Workspace is an integrated, personalized workflow management system

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designed to help clinicians operate with more speed, diagnose with greater accuracy, convey results to referring physicians faster and more conveniently, and run a practice more effectively. Version 3.0 will be available as a software-only upgrade. Philips also is featuring the new PET/CT Viewer application for the Extended Brilliance Workspace, launched in March at the American College of Cardiology meeting, which provides PET users with integrated image review and analysis environment for routine clinical evaluation of PET/CT examinations. It is adaptable to the workflow needs of individual users and substantially improves workflow and efficiency for routine clinical review. It also allows applications to be put on an enterprise network. The company also is showcasing its Astonish 2.0 image processing tool that began shipping in January. It is installed at more than 250 sites.

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News Headlines Conference News Industry News Partnerships New Products Financial News Executive Events Awards Government News Mergers & Acquisitions Regulatory News Association News "The breadth of our nuclear medicine products and solutions in PET, SPECT, molecular imaging (MI), preclinical imaging and radiation oncology promote clinical confidence for the physician and peace of mind for the patient," said Jay Mazelsky, senior vice president, nuclear medicine, for Philips Medical Systems. "Philips recognizes the importance of accurately viewing the physiological process at a molecular level and works to develop technologies that help our customers detect pathology earlier, faster and more accurately." Philips emphasized that its installed for the GEMINI TF PET/CT is growing, with more than 30 installed systems worldwide. The GEMINI TF with time-of-flight imaging has demonstrated improved image quality, reduced dose, faster scan times, and consistent image quality across all patient sizes. Dr. Jim O'Donnell, section chief of Nuclear Imaging at University Hospitals Case Medical Center said of the system, "We've really gone another giant step forward in image resolution with time-offlight. And the differential improvement in moving from conventional PET to time-of-flight is most prominent in larger patients because it overcomes the inherent physiological problems of size. The system really cleans up the scans in these larger patients."
HOME Health Imaging News

Philips' highlights enhanced PET/CT, `green' BrightView SPECT
Health Imaging News | June 6, 2007 | SNM 360 Royal Philips Electronics this week at SNM 2007 in Washington, D.C., announced enhancements to Philips GEMINI TF PET/CT, a time-of-flight PET/CT, and the nuclear medicine debut of a "green" BrightView SPECT, among other technologies.

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Also on display was the company's compact BrightView SPECT. The system's BodyGuard feature automatically contours to the patient, using a customizable scan distance preset by the operator. Also, Philips' CloseUp technologies enable higher resolution through smart software, new electronics and minimal distance between detector and patient. Philips also boasted that the BrightView is also its "green flagship" product, thus BrightView with a sustainable life cycle in mind, using less than 50 percent of the hazardous substances found in its predecessor. BrightView is also designed to offer significant advances on packaging, recycling and disposal. The company also showcased its MOSAIC HP, a part Philips' comprehensive preclinical imaging product portfolio. The system has extra-long imaging bore and long axial field of view, useful for a variety of research subjects as well as the capability to perform bio-distribution studies on a whole subject (mice) in a single bed position. Equipped with a high performance LYSO detector and optional subject handling system compatible with the NanoSPECT/CT system, MOSAIC HP addresses the key requirements of research scientists and is setting new standards in preclinical molecular imaging. Other highlights at the show included: PET/CT Pulmonary Toolkit for Respiratory Correlated Imaging ­ Respiratory correlated imaging applied to PET improves the accuracy of PET attenuation correction and Standard Uptake Value (SUV) calculations, assists in small lesion detection and facilitates more precise localization; PET/CT Viewer for Philips iSite PACS and version 1.5, providing users with an integrated, powerful, yet simple image review and analysis environment for routine clinical evaluation of PET/CT examinations. Philips has extended the availability of the PET/CT Viewer beyond the Philips Extended Brilliance Workspace to the Philips iSite PACS, along with introducing the latest release of version 1.5; NetForum PET/CT Community ­ Previously available to Philips CT and MR customers only, the NetForum PET/CT community is connecting Philips PET/CT customers from around the globe in a moderated virtual users meeting to share clinical experiences, learn from each other and optimize results; NanoSPECT/CT ­ Available through a distribution agreement with Bioscan Inc. announced earlier this year, NanoSPECT/CT will help accelerate preclinical research, the discovery of new targeted biomarkers and the development and validation of new molecular diagnostic and therapeutic applications; and Philips announced the commercial release of the JETStream Workspace 3.0, an

http://www.healthimaging.com/content/view/6654/89/

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integrated, personalized workflow solution for nuclear medicine that includes new process and image display enhancements, new image analysis tools and upgraded clinical applications for cardiac, bone, renal, salivary, lung and brain studies.

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the weekly source for radiology professionals
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vol. 19, no. 13 - March 27, 2006

>>

Philips Medical Systems
Gemini TF PET/CT system
Article available online at: http://www.rt-image.com/032706TS Philips Medical Systems, Andover, Mass., announces Gemini TF, a new PET/CT system. The Gemini TF is the first PET system to use atomic particle time-measurements to deliver increased image quality and consistency, thus assisting in earlier disease detection in patients. Gemini TF is the world's first commercially available time-of-flight PET/CT system, in which gamma rays are more accurately tracked using minute time measurements. Raising effective image sensitivity by more than two times over conventional PET, the Gemini TF delivers benefits for both patients and clinicians. Image acquisition is shortened to less than 10 minutes for a whole-body PET scan, even for larger patients, who had previously needed additional scan time. The Gemini TF also features Philips patented OpenView gantry design, which promotes patient comfort. In a conventional PET system, a decaying radioactive agent is injected into the patient. As each nucleus decays, it releases a positron, which immediately collides with an electron, releasing two gamma rays that travel away from the collision zone at 180 degrees from each other. It is these pairs of gamma rays that are observed by the PET scanner, which uses this information to calculate where the agent is concentrated, thus creating an image of the affected area. Although the gamma rays in each pair arrive at slightly different times depending on their origination, this is not traditionally measured. With time-of-flight, however, this time difference can be measured, enabling the point of origination to be more accurately predicted and leading to more accurate imaging. The combined benefits of faster sampling, longer useful imaging times from short-lived isotopes and the use of new low-efficiency tracers are set to increase the utility of PET/CT for every healthcare stakeholder. The technology also opens the pathway to enable the molecular imaging applications of the future. "This addition to our broad portfolio demonstrates our technology leadership, and our ability to translate that expertise into clinical solutions which integrate seamlessly into the patient care cycle," says Peter Cempellin, general manager of Philips' PET/CT division. "Gemini TF is a step-change for PET, delivering greatly improved performance and with it the possibility of earlier detection of disease and earlier treatment for patients in the future." -- Philips Medical Systems www.medical.phillips.com

The Gemini TF is the first PET system to use atomic particle time measurements to deliver increased image quality and consistency. (Philips Medical Systems)

http://www.rt-image.com/Philips_Medical_Systems_Gemini_TF_PET_CT_system/content=7804J05...

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Copyright © 2007, Valley Forge Publishing Group 2570 Boulevard of the Generals, Ste 220, Norristown, PA 19403 p. 800-983-7737 | f. 610-644-3688 | e. [email protected]

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420
Scintillation Material
PreLudeTM 420 (Lu1.8Y.2SiO5:Ce) is a Cerium doped lutetium based scintillation crystal that offers high density and a short decay time. It has an improved light output and energy resolution compared to BGO (Bi4Ge3O12), which has a similar density. Applications that require higher throughput, better timing and better energy resolution will benefit from using PreLudeTM 420 material. .
PreLudeTM 420 scintillator has shown up to five times the light emission of BGO. The measured energy resolution for 662 keV photons for a 30mm diameter x 15mm long crystal is 7.1% (see the energy spectrum below). A typical value for BGO is 12%. The emission of scintillation light matches well with the sensitivity spectrum of most PMTs. The quantum efficiency (Q.E.) of a standard bialkali ETI 9266 PMT is 25% at the peak of the emission.
Properties ­ Density [g/cm3]: ............................................. 7.1 Hygroscopic ...................................................... no Attenuate length for 511keV (cm): ....... 1.2 Wavelength of emission max.[nm] .... 420 Refractive index@emission max. ....... 1.81 Decay time [ns]: .............................................. 41 Energy resolution [%]: ................................. 8.0 Light output, photons per keV: ................ 32 Average temperature coefficient from 25 to 50o C (%/oC): ................................... +0.04

Counts

Wavelength (nm) Energy (keV)

igure Figure 3. PreLudeTM 420 Emission & ETI 9266 Q.E.

igure Figure 1. PreLudeTM 420 Response to 662 keV Photons

(Q.E. data courtesy of Electron Tubes, Inc.)

The 1/e decay time of PreLudeTM 420 crystal is 41ns, which is much shorter than the decay time of BGO. It is a single exponential with no long components present. This allows for higher rates, greater throughput and better timing.
Anode Signall (50 ohm, normalized)

PET applications have traditionally used arrays of BGO. PreLudeTM 420 crystal competes directly on density and surpasses BGO on energy resolution, timing and throughput. The PreLudeTM 420 material is a lutetium-based scintillator which contains a radioactive isotope 176Lu, a naturally occurring beta emitter.

t (ns)

igure 2. Figure 2. PreLude

TM

420 response to 511 keV

continued on back..

with R3241 PMT

Emission (a.U.)

Q.E.(%)

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Scintillation Products

PreLudeTM 420 Scintillation Material

Saint-Gobain Crystals has also developed a unique expertise in manufacturing millimeter-sized arrays.

Example of our precision pixel alignment technology Material: LSO

Absorption Efficiency of PreLudeTM 420
100%

USA Saint-Gobain Crystals 12345 Kinsman Road Newbury, OH 44065 Tel: (440) 564-2251 Fax: (440) 564-8047 Europe Saint-Gobain Crystals 104 Route de Larchant BP 521 77794 Nemours Cedex, France Tel: 33 (1) 64 45 10 10 Fax: 33 (1) 64 45 10 01 P.O. Box 3093 3760 DB Soest The Netherlands Tel: 31 35 60 29 700 Fax: 31 35 60 29 214 Japan Saint-Gobain KK, Crystals Division 3-7, Kojimachi, Chiyoda-ku, Tokyo 102-0083 Japan Tel: 81 (0) 3 3263 0559 Fax: 81 (0) 3 5212 2196 China Saint-Gobain China Investment Co., Ltd. 15-01 CITIC Building 19 Jianguomenwai Ave. Beijing 100004 China Tel: 86 (0) 10 6513 0311 Fax: 86 (0) 10 6512 9843 www.detectors.saint-gobain.com

90% 80% 70%
50 mm 40 mm

Percent Absorption

60% 50%
3 mm

30 mm 20 mm 10 mm 5 mm

40%
2

30%
1

Figure 4. Gamma and X-ray absorption efficiency for various thicknesses of PreLude 420 material. Data compiled by C. M. Rozsa (presented in Saint-Gobain Crystals brochure "Efficiency for Selected Scintillators.")

20%
½ mm

10% 0% 10 100 1,000 10,000

Energy (keV)

Proper operty Proper ty Density [g/cm3] Attenuation length for 511 keV (cm) Decay time [ns] Energy resolution Light output, photons per keV Average temperature coefficient from 25 to 50oC (%/oC)

PreLudeTM 420

BGO 7.1 1.0 300 12.0 9

LSO 7.4 1.15 40 10.0 26

7.1 1.2 41 8.0 32

+0.04

-1.2

-1.3

Table comparing principal propertiesof PreLudeTM 420 versus BGO and LSO
4is a 20

trademark of Saint-Gobain Ceramics & Plastics, Inc.

Manufacturer reserves the right to alter specifications. ©2004 Saint-Gobain Ceramics & Plastics, Inc. All rights reserved. (6-04)

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Society Awards Case 1:07-cv-00190-SLR

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Awards SOCIETY AWARDS

MERIT AWARD Charles L. Melcher
The 2006 NPSS Merit Award was given to Chuck Melcher. Following a background in luminescence physics and materials science as a graduate student at Washington University and as a post-doc at Caltech, Chuck began to focus on scintillation materials while at Schlumberger-Doll Research. As Program Leader of Advanced Detectors, he led a group that conducted fundamental investigations of various scintillation materials for potential use as gamma-ray detectors in geophysical exploration. These investigations led to the development of compact gamma-ray detectors for down-hole water saturation measurements in producing oil wells, a technique that continues to be a commercial standard in the industry. While at Schlumberger, Chuck invented a new scintillator material known as LSO (cerium-doped lutetium oxyorthosilicate, Lu2SiO5:Ce) which has outstanding properties for gamma ray detection. Its combination of high density and atomic number, high light output, and short decay time gave it significant advantages over previously known scintillators. LSO was quickly recognized as having particularly valuable properties for use in Positron Emission Tomography (PET), a molecular imaging technique for the early detection of diseases such as cancer and Alzheimer's. His first presentation about LSO earned an award at the NSS-MIC conference in Santa Fe, and the corresponding paper is one the most cited scintillator articles in the Transactions on Nuclear Science. In 1996 Chuck moved to CTI, Inc. to form a team that would continue to develop LSO for commercial PET applications. This team collaborated with numerous researchers world wide to further investigate fundamental properties of LSO while also developing prototype growth systems to demonstrate large scale production feasibility. The successful development of a commercial scale growth process enabled the team to design and construct of one of the largest crystal manufacturing factories in the world whose output now provides LSO crystals for hundreds of Positron Emission Tomography systems annually. The factory also produces large crystals for potential use in particle physics experiments. When CTI merged with Siemens Medical Solutions in 2005, Chuck organized a partnership between the University of Tennessee and Siemens to form the Scintillation Materials Research Center (SMRC). He joined the faculty of the Materials Science and Engineering Department at the University of Tennessee and became Director of the Center. The SMRC is a groundbreaking example of a cooperative partnership between industry and academia, providing unique research opportunities for engineering students and an integrated approach for the commercial realization of innovations in scintillation materials. LSO has become the standard against which new scintillator materials are often compared. During the 15 years since its introduction, no scintillator has yet equaled its combination of high light yield, fast decay time, high density and atomic number, and environmental stability. Chuck not only discovered and patented LSO and carried out much of the initial basic research on its properties, but he also led its development to the industrial production level and its widespread implementation in positron emission tomography (PET). It is arguably the most commercially successful scintillator of the last 20 years, now used in nearly half of the clinical PET scanners currently manufactured as well as in the vast majority of small animal PET scanners. The discovery and commercialization of LSO is often

Charles L. Melcher Merit Award

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mentioned as one of the major developments in nuclear medical imaging of the last few decades. In addition, it is now under consideration for the next generation of high energy physics calorimeters. Chuck has been an active member of the IEEE and the NPSS for many years. In addition to numerous program committees, he has served on the Radiation Instrumentation Steering Committee and the Constitution and Bylaws Committee. He currently serves as Vice Chair and Chair-elect of the Radiation Instrumentation Technical Committee. In addition, he serves as Associate Editor of the Transactions on Nuclear Science. Citation: For outstanding contributions to the field of scintillation materials, particularly for the invention, development, and commercialization of LSO scintillators and the resulting impact on positron emission tomography and nuclear medicine. Chuck Melcher can be reached at Scintillation Materials Research Center, University of Tennessee,Knoxville, TN 37996-2000; Phone: +1 865 974-0254: Fax: +1 865 974-4998: E-mail: [email protected].

RICHARD F. SHEA DISTINGUISHED MEMBER AWARD Paul V. Dressendorfer
Paul V. Dressendorfer received the B.S. degree in Physics from the California Institute of Technology in 1972, and the M.S., M.Phil., and Ph.D. degrees in Solid State Physics from Yale University in 1973, 1974, and 1978, respectively. He recently retired from Sandia National Laboratories as the manager of the Biomolecular Interfaces and Systems Department at Sandia National Laboratories. This group focused on the science of integration of biomolecular processes, biological principles, biomimetic materials, and biomolecular function into nanoand microscale systems. His earlier research activities and publications have covered a wide range of areas including semiconductor device physics, basic radiation damage mechanisms, characterization of radiation effects, hardened technology development, hardness assurance, optoelectronic devices, multichip modules, advanced electronic and microsystem packaging, thermal management, frequency devices, sensors and transducers, and microsystem electronics. He has been active in a variety of IEEE activities, including positions such as general chair of the Nuclear and Space Radiation Effects Conference (NSREC) and of the Semiconductor Interface Specialists Conference (SISC), short course instructor and chair of the NSREC, technical program chair of the SISC, IEEE Section Membership chair, IEEE Standards Committee member, and member of the NPSS AdCom, Radiation Effects Steering Group, and Radiation Instrumentation Steering Committee. He is a Fellow of the IEEE and a recipient of the IEEE Third Millennium Award. He has been the Editor-in-Chief of the IEEE Transactions on Nuclear Science since 1993, is currently the Editor-in-Chief (Chair of the Publications Committee) of the NPSS, and is the NPSS Liaison to the TAB Transactions Committee. He recently reorganized the Editorial Board and review processes for the Transactions on Nuclear Science; a similar structure is also being implemented in the Transactions on Plasma Science. Citation: In appreciation of 14 years as editor for NPSS. Special recognition as Editor-in­Chief for reorganizing and implementing an effective operating structure for the Transactions on Nuclear Science. Paul Dressendorfer can be reached at [email protected].

Paul V. Dressendorfer Richard F. Shea Distinguished Member Award

EARLY ACHIEVEMENT AWARD

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JOHN W. LUGINSLAND
John Luginsland received the B.S.E, M.S.E, and Ph.D. degrees from Department of Nuclear Engineering at the University of Michigan in Ann Arbor, Michigan. His doctoral research involved the theoretical and computational analysis of two-beam accelerators, field emission physics, and coherent microwave generation. In 1996, he joined the Air Force Research Laboratory at Kirtland AFB, NM ­ first as a National Research Council Resident Postdoctoral Research Associate, and later as a staff member in the Center for Plasma Theory and Computation. In 2001, he moved to Science Applications International Corporation as a senior scientist and program manager. In 2003, he joined NumerEx of Albuquerque, NM, at a satellite office in Ithaca, NY. At AFRL, Dr. Luginsland performed research advancing the state-of-the-art in both high power microwave (HPM) sources and high performance computational models of electromagnetic devices. He led a team in basic research of multidimensional space-charge limited flows that led to mitigation of pulse shortening in the magnetically insulated line oscillator. He also participated in the development of ICEPIC, a massively parallel electromagnetic particle-in-cell code, with application to HPM sources. He and his colleagues were honored with the Air Force's Advanced Technology Development Award during this time. At SAIC, Dr. Luginsland developed parametric design tools for advanced armor and survivability systems, which remain in use today. He was a program manager and test planner in integrating these systems into next generation platforms. At NumerEx, Dr. Luginsland has applied computational plasma physics to closely support experimental technology development at various phases of maturity, in compact HPM sources, emission physics and cathode designs, MHD effects in high power fuses for survivability systems, electrically enhanced combustion, and quantum vacuum nanoelectronics. His wider interests include the coupling of parametric and first-principles physics software, high-performance computing and optimization algorithms, and application of virtual prototyping to speed development and deployment of electromagnetic high technology systems. The award will be presented at the Pulsed Power Plasma Science conference in Albuquerque, NM in June 2006. Citation: For contributions to the development and application of theoretical and computational methods leading to enhanced understanding and improved experimental performance of high current diodes and high power microwave sources. John W. Luginsland has been a member of the IEEE and NPSS since 1994, and can be reached at NumerEx, 401 E. State St., Suite 304, Ithaca, NY 14850; Phone: +1 607 277-4272; Fax: +1 607 697-0212; E-mail: [email protected]

John W. Luginsland Early Achievement Award

GRADUATE STUDENT ACHIEVEMENT AWARDS Xin Dai
Xin Dai was born in Hubei China in 1976. He received his B.E. degree in 1996 and M.S. degree in 1999, both in Electrical Engineering from Huazhong University of Science and technology, Wuhan, China, and the Ph.D. degree from the University of Tennessee, Knoxville, TN, in 2006. He is currently a Postdoctoral affiliate at Plasma Science Laboratory at the University of Tennessee at Knoxville. His research interests include industrial plasma research and application, especially at atmospheric pressure, pulsed power and high power electronics. Dr. Xin Dai is a member of IEEE, AIAA and APS.

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Carrie B. Hruska
Carrie Hruska has been named a recipient of the IEEE NPSS Graduate Scholarship Award given to recognize contributions to the fields of Nuclear and Plasma Sciences. Hruska is a graduate student at Mayo Clinic College of Medicine in Rochester, MN and will graduate with a Ph.D. in Biomedical Engineering in May 2007. She received her undergraduate degree in electrical engineering from South Dakota State University in 2002. Hruska's doctoral thesis research is focused on the use of small pixilated detectors for a nuclear medicine technique to image breast cancer, called Molecular Breast Imaging (MBI). She is currently working with a prototype CZT detector, and the goal of her work is to advance MBI by examining the patient-related factors that limit tumor detection, optimizing the technical parameters of the imaging system, and developing a method to localize tumors in the breast. The central hypothesis is that recent advances in small detector technology combined with new radiopharmaceuticals will permit the development of an MBI system that will provide reliable detection and localization of small breast tumors (< 10 mm). MBI is currently under evaluation at Mayo as a screening technique for women with dense breast tissue who are at increased risk for breast cancer.

Xin Dai

Carrie Hruska

Randolph McKinley
Randolph McKinley recently received his Ph.D. in Biomedical Engineering from Duke University in Sept. 2006. He currently works in the Multi-Modality Imaging Lab (MMIL) at Duke concentrating on X-ray computed mammotomography, a dedicated 3D breast imaging technique, which includes a practicable quasimonochromatic cone beam X-ray source that can move about an object 3dimensionally collecting transmission data. In addition, he holds a Master of Science in Electrical Engineering from Columbia University and Bachelor of Science degrees in both Biology and Electrical Engineering from University of New Brunswick.

Randolph McKinley

Xing Zhou
Xing Zhou is in the process of completing her PhD research in the interdisciplinary graduate program in materials science at Vanderbilt University. She has made significant contributions to the understanding of the separate and combined effects of bias-temperature stress and ionizing radiation exposure for MOS devices with high-K dielectric materials. Xing has authored 11 publications, and was first author on four of them. A paper on which Xing was first author, "Bias-temperature instabilities and radiation effects in MOS devices," was one of 11 papers nominated for the Outstanding Conference Paper Award at the 2005 IEEE Nuclear and Space Radiation Effects Conference (IEEE NSREC) in Seattle, WA. She also received a Paul Phelps Continuing Education Grant for the 2006 IEEE NSREC in Ponte Vedra Beach, FL. Xing Zhou can be reached by e-mail at: [email protected]

Xing Zhou

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Society Awards Case 1:07-cv-00190-SLR

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Filed 07/20/2007

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