Marlborough device maker receives FDA warning regarding implantable devices
Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...
STAT2d
How the FDA and CMS worked together on a new approach to paying for digital mental health treatments
By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
JD Supra3d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
STAT10d
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
Healio6d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Plastics News1d
FDA warns Hologic to do more to prevent harm from component in recalled implant markers
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
JD Supra4d
FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal ...
Modern Healthcare12d
FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
Becker's Hospital Review1d
FDA spotlights risks in medical device supply chain
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.