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
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul
Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.