IMAGIN MEDICAL HIRES DIRECTOR OF REGULATORY AFFAIRS
Imagin Medical Inc. has hired Pam Papineau as the director of regulatory affairs.
Ms. Papineau has over 30 years of experience in quality and regulatory affairs with Baxter, Boston Scientific and Cogentix (Vision-Sciences), and has served as a consultant on a wide variety of devices that includes endoscopy, imaging, GI/GU, orthopedic and cardiovascular. Ms. Papineau has successfully prepared dozens of Food and Drug Administration premarket submissions and European Union (EU) technical files to support CE marking of a broad spectrum of medical devices and has overseen numerous clinical studies entailing protocol development, reporting and management of clinical research organization (CRO) services. Ms. Papineau is an ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and Certified Biomedical Auditor (CBA), an ISO 13485:2016 lead auditor, and holds Regulatory Affairs Professional Society (RAPS) certifications for the United States, EU and Canada. Ms. Papineau will work with Hogan Lovells, the company's legal counsel, preparing for a presubmission meeting with the FDA and follow-on activities through the regulatory approval process.
"As the project progresses, we continue to put the needed talent in place to bring the i/Blue Imaging System to market," said Jim Hutchens, Imagin's president and chief executive officer. "We have worked with Pam in the past and we're excited to have her expertise on our team."
About Imagin Medical Inc.
Imagin Medical is developing imaging solutions for the early detection of cancer where endoscopes are used. The company believes it will radically improve the way physicians detect cancer. Imagin's initial target market is bladder cancer, a major cancer worldwide, the sixth-most prevalent in the United States, and the most costly cancer to treat due to a greater than 50-per-cent recurrence rate. Developed at the Lawrence Livermore National Laboratory, this advanced, ultrasensitive imaging technology is based upon improved optical designs and advanced light sensors.
