A local medical device startup has secured the FDA green light its pharmacist founder has been eyeing for more than a decade.

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a ...

AI is a transformational force in healthcare, but without cybersecurity as its foundation, it becomes a high-stakes gamble.

If the goal of these cuts was to make the government leaner, the result has been to make it weaker. And in the realm of public health, weakness can be deadly.

This marks the latest recall-related issue for HeartMate in recent years. Last June, the FDA deemed another recall as serious ...

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important ...

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. The device is an atrio-ventricular interval modulation therapy, meaning it ...

Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, ...

DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to ...

Sonavex announced that it received FDA 510 (k) clearance for its AI-enabled EchoMap device with 3D ultrasound capabilities.

The commissioner of the FDA welcomed three new leaders to the agency this week, including a new deputy commissioner.