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

The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...

Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore communication for ...

The US FDA has approved Element Science’s premarket approval (PMA) application for its Jewel Patch Wearable Cardioverter ...

The FDA has approved Edwards Lifesciences' SAPIEN 3 TAVR platform for the treatment of patients with asymptomatic severe ...

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

The apparent reversals are the latest examples of the haphazard approach to agency cuts that have shrunk FDA’s workforce by ...

Neuralink said on social media that it received FDA breakthrough device designation for treating individuals with severe ...

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

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