People In Brief
Device matrix leader: Jonathan Sackner-Bernstein assumes the role of associate director for post-market operations Sept. 2, tasked with overseeing CDRH's recently launched matrix organization, FDA announces Aug. 29. Sackner-Bernstein is the program's first permanent director, after acting heads Diane Mitchell and Don St. Pierre helped to set up the program (1"The Gray Sheet" July 21, 2008, p. 7). Prior to joining FDA, Sackner-Bernstein was chief medical officer at New York City-based contract research organization Clinilabs. Previously, he served on the faculty at Columbia University and was associate chief of cardiology at St. Luke's-Roosevelt Hospital. In addition, Sackner-Bernstein has sat on the cardiovascular and renal drugs advisory panel for FDA's drug center and the device center's dispute resolution panel
More from Archive
More from Medtech Insight
Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.