FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for tech companies and investors.

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

W. L. Gore & Associates has secured FDA approval for the GORE VIABAHN FORTEGRA Venous Stent — previously known as the GORE ...

The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its request for comment, factors such as changes ...

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...

The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real ...

Ceribell’s LVO Stroke tool is underpinned by the same EEG monitoring technology used in its seizure and delirium monitoring ...

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...

The global market for contract manufacturing of medical devices is estimated to grow from $96.4 billion in 2025 to reach $155.2 billion by 2030, at a compound annual growth rate (CAGR) of 10% from ...