The problem with pulse oximeters your doctor probably doesn’t know.
The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
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.
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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 ...
Investing News Network on MSN3d
Top 5 Small-cap Medical Device Stocks (Updated January 2025)
The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device ...
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 ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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 ...
Becker's Hospital Review1d
3 medical device recalls
Here are three recent recalls reported to the FDA: ...
JD Supra5d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...
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 ...
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 ...