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 ...
FierceBiotech2d
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 ...
Becker's Hospital Review2d
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.
vator13d
The FDA outlines draft guidance on AI for medical devices
Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...
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 ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
Forbes2d
The 8 Best At-Home Laser Hair Removal Devices Of 2025
After speaking with two experts and gathering personal recommendations from Forbes Vetted testers, we landed on the eight best at-home laser hair removal devices, all of which are FDA-cleared.
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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 ...
JD Supra2d
FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...
JD Supra5d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation ...