When Whoop introduced its new hardware and membership tiers back in May, one of the devices was called the MG, with the ...

The agency claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.

The Food and Drug Administration will now require medical devices meet specific cybersecurity guidelines after years of concerns that a growing number of internet-connected products used by ...

The FDA decided it was time to modernize its approach to medical device cybersecurity. Therefore, it updated Section 524B of the Food, Drug, and Cosmetic Act (FD&C Act). What Manufacturers Need To ...

As the US Food and Drug Administration publicizes its plans to overhaul the process for manufacturers that want to market medical devices, an investigation by a nonprofit journalism group is ...

As medical technology evolves, advanced packaging must meet rising demands for safety, sustainability, and efficiency in healthcare.

Medical devices like heart monitors, which are under the purview of the Food and Drug Administration, have cybersecurity vulnerabilities that aren’t frequently exploited but nevertheless pose risks to ...

MedTech Dive downloaded the FDA’s list of AI/ML-enabled medical devices on Sept. 6, 2024. The FDA last updated the database on Aug. 7, 2024.

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products ...

They can tell you this is a class I medical device. And they can make it seem so official, because it is official. They really are registered with the FDA to produce a class I medical device.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device—“a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious ...

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...