The FDA is releasing the first-ever guidance on how the pharmaceutical industry can use AI. Nick Kostos and Femi Abebefe ...

AI can compare thousands of images to uncover dangerous patterns, create ultra-high resolution scans from low-res images and ...

Of the 1,757 total AI use cases reported by federal agencies last year, 227 of them were listed as safety- or ...

The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...

In this edition of InnovationRx, medical debts will be erased from credit histories, this farm is doubling down on raw milk ...

Shares of Sana Biotechnology Inc. (NASDAQ: SANA) were trading at $4.97, up $3.32, or 201%, on first results from an investigator-sponsored, first-in-human study transplanting UP-421, an allogeneic ...

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.

The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

Withings, a connected health company, has expanded its cardiovascular products with BPM Vision, an advanced blood pressure monitor.

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...