Ongoing Funded Projects

Ongoing Funded Projects:

Clinical Trial of Imaging AI Products for FDA Clearance:

In the past 30 years, we have been working on medical imaging CAD/AI research and have collaborated with our industrial partners on the development of medical imaging AI products. We also helped industrial partners perform AI product evaluation studies as a part of clearance processes required by the FDA. As the evaluation team, we consult with the sponsor to develop an evaluation project plan including (1) assist the sponsor in developing a Q-submission to discuss with FDA if appropriate, (2) assist the sponsor in developing product claims [intent to use], (3) select proper study methodology, (4) check-up image data quality that meets inclusion criteria, (5) estimate data size and number of readers needed to obtain statistically significant results, (6) develop a complete and excusable study protocol, (7) apply an IRB for the study, (8) register clinicaltrial.gov, (9) assist the sponsor in developing informed consent form for study participants, (10) recruit experts to confirm and establish the truth for the test data-set, (11) review the test data-set to ensure proper distribution of the data [mainly done by the clinical director], (12) recruit study readers, (13) perform stand-alone machine study with the test data-set, (14) assist the sponsor in designing sequence of study functions on the computer workstation,  (15) prepare and set-up a proper study room for each reader to perform the study, (16) perform rehearsal of the reader study [training session followed by study session], (17) execute the reader study [training session followed by study session], (18) submit output data of the study for statistician's analysis, (19) write a complete study report based on the study protocol and study results, (20) assist the sponsor in filing the FDA clearance application, (21) submit output data of the study to FDA per FDA's request, and (22) answer FDA's questions.  We welcome comments and inquiry about potential medical image related evaluation study and clinical trial.