About FDA
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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 |
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| 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 |
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