News

BioSpace1h
FDA’s AI Rollout Raises Questions Around Readiness, Legality
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...
New FDA Chief Wants to Fast-Track Some Drugs, Use More AI
And offering a fast-track to approve drugs the Trump administration views as a priority. Welcome to the new Food and Drug ...
STAT9d
As AI device market grows, FDA’s accounting goes silent
As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.
FDA probes deaths of boys taking Sarepta Duchenne drug
The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...
Healio5d
Q&A: FDA expands approval of wearable device to treat nasal congestion in adolescents
The FDA expanded the approval of the SONU Band to include the treatment of patients aged 12 years and older with moderate to ...
dvm3603d
FDA clears new energy-efficient MRI scanner for human and veterinary use
The FDA has cleared a 1.5 tesla (T) platform for magnetic resonance imaging (MRI)—the Magnetom Flow.Ace—by Siemens Healthineers, a global provider of healthcare equipment. The system features a closed ...
Becker's Hospital Review9d
FDA’s list of authorized AI-powered medical devices quietly grows
The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare. The agency’s AI/ML-Enabled ...