Customer Milestones: Ketryx signed leading global MedTech manufacturers, including innovators in AI medicine like RadNet, HeartFlow, and Nutrino, as well as numerous Fortune 500 organizations. The ...

What will shape AI governance? Industry leaders share key insights, highlighting diverse yet interconnected factors driving progress in ethics, regulation, and tech.

(AI). AI technologies such as machine learning, computer vision, natural language processing and reinforcement learning ...

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The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.

The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

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

On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) ...

Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...

The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...