Almost half of FDA-approved AI medical devices are not trained on real patient data, research reveals
Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation ...
dermatologyadvisor10h
FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
Consumer Reports12y
Dangerous medical implants and devices
Tens of millions of Americans live with medical devices implanted in ... 123 studies done on high-risk cardiovascular devices that received FDA approval between 2000 and 2007.
Becker's Hospital Review9d
FDA's plan to tackle medical device shortages: 4 notes
To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...
JD Supra9d
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...
STAT1mon
Save the Food and Drug Administration by breaking it up
The FDA is a top — maybe even the top — regulator in the world for approving new medicines. Trust in the FDA’s drug approval authority ... the-counter drugs, medical devices, diagnostics ...
PharmaTimes29d
FDA approves Sequana Medical’s Alfapump for ascites treatment
Sequana Medical NV has announced the US FDA approval of its Alfapump system for treating recurrent or refractory ascites due to liver cirrhosis. This approval marks Alfapump as the first ...