Yahoo

FDA seeks industry feedback on AI medical device safety monitoring

The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...

FDA seeks feedback on monitoring real-world performance of AI devices

The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.

Rocket Doctor Partners with Remmie to Bring FDA Approved and Health Canada Cleared Smart Otoscope to Patients

Rocket Doctor has entered into a reseller agreement with Remmie, Inc., maker of the Remmie 4, an FDA approved and Health Canada Medical Devices Establishment Licence (MDEL) cleared USB-smart otoscope ...
Medical Design & Outsourcing

Medical device manufacturers need to act now on post-quantum cryptography

Quantum computing may sound theoretical, but the implications are very real and fast-approaching, and medical device manufacturers need to start taking action. This piece outlines what PQC is, where ...
MassDevice

FDA clears Distalmotion Dexter surgical robot for hysterectomy

Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter robotic surgery system in hysterectomy.
WXYZ

FDA vape crackdown leaves smoke shops facing an uncertain future

The federal government seized over $86 million in vape devices in September, the largest seizure of its kind. Recent federal actions are leaving some smoke and vape shops facing uncertainty about ...
Becker's Hospital Review

FDA expands Early Alert program to all medical devices

The FDA has expanded its Early Alert program to give the healthcare industry earlier visibility into potential high-risk medical device issues. The agency’s Center for Devices and Radiological Health ...
STAT

Fights over Tylenol, SSRIs highlight the enduring lack of pregnant women in drug trials

Shutting pregnant women out of clinical trials to protect them and their babies has had the opposite effect, experts say.
MedTech Dive

FDA expands early alert program to cover all medical devices

After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially high-risk safety events.
HealthDay on MSN

FDA Authorizes Essilor Stellest Eyeglass Lenses for Children With Myopia

The U.S. Food and Drug Administration has authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, with or without astigmatism, and to slow the progression of the disease in ...
Opinion
BioSpaceOpinion

Opinion: Fate of FDA’s Laboratory-Developed Test Final Rule Hints at Chevron Overturn’s Ramifications

In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency authority, a judge ruled that the FDA does not have authority to regulate tests ...

FDA Finds Radioactive Contamination in This Popular Fall Spice

FDA said in a statement: "No product that has tested positive or alerted for Cs-137 has entered U.S. commerce. The FDA took immediate action to protect consumers by detaining the shipment and ...