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CDRH Cooperative Research and Development Agreements (CRADAs)

 CDRH Active CRADAs (October, 2009)

CRADA Title Public Health Need Partner Government PI Summary Page
Collaboration on Numerical Models and Tools - "The Virtual Family" (#104-05) Develop high-resolution anatomical whole-body models of an average man, woman, and two children. These models will improve computational methods for assessing radiation exposure and the safety and effectiveness of radiological devices. Foundation for Research on Information Tech. in Society - IT'IS Wolfgang Kainz  
Measurements of Computer Modeling to Evaluate the Safety of Medical Implants by Examining Leads of Cardiac Rhythm Management and Neurostimulation Devices in the Presence of Electromagnetic Fields from Magnetic Resonance Imaging (#114-06) Develop test methods and guidelines testing Magnetic Resonance (MR) compatibility with medical devices. Biophan Technologies, Inc. Howard Bassen  
High-dynamic-range display of medical images (#123-07) Determine whether high-dynamic range display improves diagnostic detection in radiological images. FIMI/Phillips ( Italy) Aldo Badano  
Optical techniques for the non-invasive 3-D characterization of biomedical ultrasound beams (#128-07) Develop tools to prevent adverse events when using high intensity focused ultrasound St. Jude Medical/Epicor Medical Ronald Robinson  
Non-invasive assessment of individuals at risk for diabetes (#143-08) Develop a prototype for non-invasive early detection of ocular disease and diabetes. Eyelight Diagnostics, Inc Michelle Chenault  
X-ray detector models for imaging breast cancer (#148-08) Optimize the diagnostic value of emerging 3D imaging systems such as breast tomosynthesis while decreasing radiation dosage. Ginzton Technology Center (Varian Medical Systems) Aldo Badano  
Software for Bayesian Clinical Trials (#150-09) Create industrial strength software that will design and analyze Bayesian clinical trials to reduce burden on sponsors and FDA statisticians. Cytel, Inc Gerry Gray  
Software Re-engineering and Forensic Analysis (#153-09) Explore the application of Fraunhofer’s SAVE (Software Architecture Visualization and Evaluation) tool in medical device error code analyses to strengthen regulatory software forensics. Fraunhofer USA, Inc - Center For Software Engineer Paul Jones  
Optical Fiber-Based Instrumentation for Monitoring Breath Biomarkers (#86-05) Develop a minimally-invasive, sensitive and environmentally friendly detection tool to test for disease or health hazards. Nanosonic, Inc. Ronald Waynant  
Biomechanics and Genomics of Vascular Dysfunction and Healing (#87-05) Develop an understanding on the development of atherosclerotic disease and vascular healing from therapeutic vascular interventions. University Of Pennsylvania William Pritchard  
Development of a Nano-Particle Influenza Assay (#147-09) Evaluate whether a nano-particle assay will be earlier and more accurate in detecting highly pathogenic influenza viruses. NanoSphere, Inc. CBER lead: Zhiping Ye
CDRH: Xing Tang
Co-Development of Drugs and Pharmacogenomic Tests (#120-06) Optimize coordination of drug and diagnostic test development. Novartis Institutes for Biomedical Research, Inc. CDER lead: Federico Goodsaid
CDRH: Zivana Tezak