Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

Privacy and artificial intelligence (AI) regulation and enforcement have been heating up in the U.S. and around the world.

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...

Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...

Jen Lamppa, VP of Commercial Strategy at Inovalon, says that RWD will be held to the same scrutiny as trial data if used in ...

(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be ...

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...

PRNewswire/ - MolecuLight today announced that its MolecuLightDX(R) wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The ...

January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...