Director Software Development
Firstsense Medical
FIRSTSENSE MEDICAL (FSM) is developing a revolutionary breast cancer screening device with 96% projected sensitivity (detection rate) when combined with patient history and ultrasound in select cases. It is painless, radiation free and takes about 6.5 minutes and is done in a doctor's office.FSM has two models for screening. FIRSTSENSE Breast Exam® (FSBE) and SENTINEL. FSBE uses Advanced Thermal Profiling, Infrared and 3D cameras to view breasts from front and sides. The SENTINEL tester has a stationary IR camera and mirrors to view sides of the breast. Sophisticated proprietary software assists the clinician with analytical support. Both systems are qualified as a Class I device, with FDA 510(k) clearance as an adjunct to a mammogram. They use thermal images and a cold challenge analyzed by an in-house lab (1Q17 launch). FSM is also pursuing many clinical trials at major hospitals and universities -- St. Joseph Mercy at Pontiac and Ann Arbor MI, Univ. of Toledo, OH, and UCLA. My responsibilities include:The management of the software development activities of the bio-robotics system related to the medical image diagnosis, robot controls, sensor integration, embedded systems, cloud based data analysis, bio-statistics and user interactions. Directing the Software department staff, department budget, project proposals, requirements and go-to-market strategies. Involved in the product development of breast cancer tester, system architecture, functional aspects, specifications, use cases, V&V, HIPAA, FMEA, FDA level standards and documentation. Leading the FDA 510K clearance process and maintaining the IEC 62304 software standards and quality. I have filed over 3 patents and several trade secrets in areas of IR image filtering, autonomic nervous system response, CAD, etc.“Apparatus and method for detecting a presence of cancer,” Paul G. Angott, Pavan Vempaty, et al. US Patent 20150257650 and 20150257651 [Sept, 2015].