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 ...

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

FDA clearance is a vital milestone for ASX medical device companies, opening access to the US market while navigating the regulatory process.

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 ...

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 ...

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

The FDA’s move to nix its ‘Final Rule’ comes in response to the legislation’s strike down in a Texas court in March 2025.

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 ...

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 ...

Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.

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

The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31 ...