New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
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 ...
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 ...
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 ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...
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FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
JD Supra4d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
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, ...
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.
Becker's Spine Review1d
7 spine, orthopedic devices earning FDA clearance in 1 month
Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.