The US Food and Drug Administration (FDA) has launched Technology-Enabled Meaningful Patient Outcomes (TEMPO), a pilot that ...

December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered ...

The U.S. Food and Drug Administration (FDA) is seeking comments on methods of assessing the real-world performance of AI-enabled medical devices, including generative AI. Prior FDA draft guidance has ...

Connecting insulin pumps, heart-rate monitors, and other medical devices in the internet of things has transformed patient care. But the security of these solutions is, in too many instances, not ...

Smartphones and tablets are not meant to last forever, even if their price tags might indicate otherwise. Though some last longer than others, the reality is that the average lifespan of a smartphone ...

On your Windows PC, there's a lot happening behind the scenes that you rarely notice. Processes are running, drivers are constantly exchanging information, and hardware components are quietly working ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...