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 ...
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.
FierceBiotech1d
FDA’s device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
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 ...
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FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...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 ...
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 ...
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.
Tariff threats, drug pricing will be 2 key pharma issues during Trump's first year
Like many industries preparing for Donald Trump's second term as president, the prospects for the healthcare industry are a ...