News

FDA claims victory with Elsa rollout, but insiders say the AI tool is half-baked
The Food and Drug Administration has officially launched "Elsa," a generative artificial intelligence platform designed to ...
Scientists argue for more FDA oversight of health care AI tools
An agile, transparent, and ethics-driven oversight system is needed for the U.S. Food and Drug Administration (FDA) to ...
Fierce Biotech1h
FDA clears first AI tool for breast cancer risk prediction from startup Clairity
Startup Clairity scored a greenlight from the FDA for the agency's first artificial intelligence tool designed to predict ...
MPR1h
FDA Clears Wearable Device to Treat Nasal Congestion in Children
Sonu, an AI-enabled wearable device, is now approved for use in pediatric patients aged 12 years and older for the relief of moderate to severe nasal ...
California petitions FDA to undo RFK Jr.’s new limits on abortion pill mifepristone
California and three other states have called on the FDA to ease new restrictions on the abortion pill mifepristone, which ...
RadNet Acquires See-Mode Technologies to Enhance AI Ultrasound Imaging
RadNet, Inc. (NASDAQ:RDNT) has moved to strengthen its prospects on the use of artificial intelligence to enhance ultrasound ...
BioSpace5h
AI’s Role in Decoding the FDA’s New Regulatory Communications
In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can ...
FDA’s New AI Tool Cuts Review Time From 3 Days To 6 Minutes
The U.S. FDA announced this week that it deployed a generative AI tool called ELSA, now in use by staff across the agency, ...
JonesTrading Maintains Buy Rating on Day One Biopharmaceuticals (DAWN) Following Ojemda’s FDA Approval
The analyst supported the positive rating with Ojemda’s potential, which is a prescription medicine that treats certain brain ...
FDA rushed out agency-wide AI tool—it’s not going well
FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't ...
FDA approves AI technology to help improve breast cancer detection
A breakthrough in AI breast cancer detection technology has been approved by the FDA. The tech company, “Clarity,” is responsible for the first FDA-approved AI platform that helps predict a woman’s ...
Becker's Hospital Review22h
FDA AI tool slow to overcome shortcomings: 4 notes
A new FDA artificial intelligence tool designed to streamline medical device reviews is faltering in its early rollout stages, raising concerns for agency staff and ethics experts about its ...