JD Supra10h
FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...
JD Supra1d
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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
STAT7d
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 ...
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
FDA approves Zyn nicotine pouches, citing health benefits for adult smokers
Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris ...
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 ...
CNN10d
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
“This draft guidance is aligned with the FDA’s broader commitment to helping facilitate the development of high-quality, safe, and effective medical devices,” Dr. Michelle Tarver, director ...
FDA Approves Feasibility Study with SeaStar Medical’s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome
Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), ...
New FDA rules to reduce racial bias in some common devices measuring oxygen in blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
Forbes24d
Are The FDA’s New Regulations On Medical Devices Making A Difference?
In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...
Advocates urging FDA to ban shock device used in Mass. school ASAP
There's an urgent push underway to get the U.S. Food and Drug Administration to finally ban the devices that administer ...
Yahoo Finance9d
FDA finalizes guidance on device shortage reporting rules
The final version, which the agency published Monday, retains the vision the FDA proposed in its second draft and adds information on the devices affected by the guidance and the impact of revised ...