Mr. Shein works with CardioMed Device Consultants as an affiliate consultant. Mitchell is an accomplished Biomedical Engineer with an extensive career at FDA’s Center for Devices and Radiological Health (CDRH) in the Division of Cardiovascular Devices. In his 30 years at CDRH, he served for 20+ years as an Agency Expert in Cardiac Pacing where in addition to cardiac pacemakers he was also responsible for the review of external and implantable defibrillators. He subsequently served 7+ years as the Branch Chief for the Pacing, Defibrillation and Leads Branch and the Implantable Electrophysiological Devices Branch. In the final year of his Federal career, Mitchell served as a Deputy Director in the Division of Cardiovascular Devices. Prior to his years at FDA, Mitchell began his career in Federal service as a Patent Examiner with the US Patent and Trademark Office, responsible for reviewing devices that applied electricity to the body for therapeutic purposes.
Mr. Shein is an expert in cardiovascular implantable electronic devices (CIEDs), with an emphasis on the premarket regulatory pathways for medical devices. His other primary areas of interest include cardiac electrophysiology; electromagnetic compatibility and electromagnetic interference (EMI) of active implantable devices; the clinical impact of exposing patients with active implantable devices to the electromagnetic environment specific to magnetic resonance (MR) imaging; and clinical trial design for electrical stimulation therapies to treat cardiac dysrhythmia and heart failure.
Mr. Shein is also an active member in the cardiac pacing and defibrillation standards community at both national and international levels. He is a member of several professional societies including Association for the Advancement of Medical Instrumentation; Heart Failure Society of America; and is a Fellow of the Heart Rhythm Society.