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 ...
JD Supra19h
FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...
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 ...
JD Supra20h
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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
MassDevice1d
The top 10 cardiac device stories of 2024
Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug
Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational ...
Healio3d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
Modern Healthcare10d
FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
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), ...