David Humbert

David Humbert brings over twenty-five years of medical device regulatory experience to Zelegent, Inc., including managing successful approval applications of both active implantable devices like the WorldHeart left ventricular assist system, and minimally-invasive devices similar to Zelegent’s new tool. He first met Dr. Arrow when he joined cardiovascular device manufacturer Arstasis, Inc. and managed the 510(k) submission process for that company’s minimally-invasive vascular access device.

Mr. Humbert’s career has included directing the regulatory efforts at Emphasys Medical and Arstasis, Inc. from 2007-2009, and supporting several Class III medical device submission projects for Oxford International and Black Diamond Networks from 2009-2014. He was Director of Regulatory Affairs at WorldHeart, Inc. from 2001-2007, a Corporate Consultant to the Regulatory Affairs group at Boston Scientific from 1997-2001, and supported the broad Regulatory Affairs function at Guidant Corporation’s Devices for Vascular Intervention, Inc. from 1990-1994. He was one of the first 500 regulatory professionals in the U.S. to earn the Regulatory Affairs Certified (RAC) credential in 1993.