Device Week Podcast – Episode 3
This article was originally published in The Gray Sheet
Executive Summary
This week, "Gray Sheet" reporters and editors discuss our exclusive interview with FDA's Robert Califf and the agency's ongoing efforts to reform combination product regulations, Medicare reimbursements for molecular diagnostic tests, efforts to repeal the medical device tax, earlier than anticipated approval of Edwards Lifesciences' latest transcatheter aortic valve system and more.
You may also be interested in...
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.