Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...
A Maryland Heights-based manufacturer of drug-delivery devices won a multimillion-dollar federal contract to produce a ...
CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain ...
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 ...
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
Investing News Network on MSN4d
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 ...
Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...
It is not alone, as other health systems discover that reprocessing single-use medical devices can be a win-win for finances ...
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