By Jeff Shuren MD JD & William Maisel MD MPH – Since the onset of the COVID-19 pandemic, staff at the FDA’s Center for Devices and Radiological Health have worked tirelessly to manage unprecedented workload demands to help increase access to high quality, critical products that are essential to our nation’s pandemic response.Read More
The Centers for Medicare and Medicare Services is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule because of concerns that the provisions in the final rule may not have been sufficient to protect Medicare patients.
By Jeff Shuren MD JD & William Maisel MD MPH – At the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, we are committed to protecting the public health by ensuring patients have more timely access to safe, effective, and high-quality medical devices.
By Paul Nadrag – As new variants emerge, COVID-19 continues to have healthcare providers’ top focus. Knowing this, criminals are using the pandemic as cover to inundate hospitals, health systems and other providers with surge after surge of cyberattacks.
By Dan Matthews – Every year that goes by brings new exciting developments in the world of healthcare that are helping us to live healthier and longer lives. A great advancement in this regard is IoT. However, as with any form of technology, IoT does have its fair share of challenges as far as cybercriminals are concerned.
By Janet Woodcock MD – The U.S. Food and Drug Administration’s Devices Program is responsible for the regulation and oversight of a wide range of medical devices that patients and their health care providers use every day.
By Lee Barrett – The COVID-19 pandemic has changed the healthcare industry as we know it – from the physical way care is administered to the adoption of emerging technologies used to triage and monitor those infected.
By Stephen M. Hahn MD – One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections.
New On Demand Dr. Nick: The Incrementalist: With guest Jeremy Elias, Founder & CEO of TrackMy Solutions, a company taking on the challenge of keeping track of all the devices and technology.