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November 2, 2023
On my continuing coverage of generative AI used for mental health, I take a look at the latest trends and what is coming down the pike. Get ready for what will happen.
August 18, 2023
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device...
January 20, 2023
In 2022, FDA retreated from a flexible approach to its regulation of digital health in two key areas: (1) its PreCertification Program for software as a medical device (SaMD) and (2) its guidance...
January 3, 2023
Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable...
November 14, 2022
September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical...
October 15, 2022
In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to...
October 6, 2022
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does...