Moshe (Michael) Kasser, Ph.D. has 15+ years of experience with premarket FDA regulation of medical devices. After obtaining his doctorate in radiation modification of biomaterials, he served a lead FDA reviewer in the orthopedics division. Upon making aliya 11 years ago, Dr. Kasser joined the medical device group at Hogan Lovells, where he has helped hundreds of medical device companies (most of which are Israeli) to achieve U.S. marketing approval. Recently, Dr. Kasser was promoted to Senior Director of Regulatory Strategy, wherein he leads Hogan Lovells’ Israeli office to continue to assist medical device companies to clear FDA hurdles and bring novel technologies to the U.S. market.
This includes cutting edge technologies such as brain/computer interfaces, robotic surgical systems, cartilage replacement devices, wearable sensors, digital health, and many others. While he assists companies globally, the majority of his work focuses on assisting Israeli companies, most of which are small startups.
Dr. Kasser provides deep, technical knowledge in the regulatory aspects of mechanical testing, MRI safety testing of implants, biocompatibility testing, chemical characterization, and electrical testing. He published articles in both scientific and regulatory journals on a variety of topics.