FDA warns of thermal issues with Philips DreamStation 2 CPAP machines

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 30. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Zilia this week won an FDA 510(k) clearance for a retinal camera. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the retinal camera is designed for, how it works and what's next for the company.  ReValve reported one of the first successful first-in-human implants for its next-gen transcatheter mitral valve replacement. Hear about the procedures and what doctors thought about using the valve replacement. BiVacor received investigational device exemption from the FDA to begin feasibility studies of its artificial heart. Whooley details the technology that goes into the artificial heart and some of the plans behind the upcoming studies.  The first patient was enrolled in Penumbra's study of its computer-assisted vacuum thrombectomy system. Learn more about the system in today's episode and what this trial will evaluate.  Philips has announced thermal issues with some of its DreamStation 2 CPAP machines. Kirsh and Whooley talk about the latest warning from the FDA, the risks involved with using the device and Philips' response.