FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and drug label updates.

For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...

In a recent interview, Food and Drug Administration Commissioner Marty Makary declared that Medicare should automatically cover FDA-designated breakthrough devices — a rare and refreshing commonsense ...

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability Office (GAO) report only strengthens that conclusion.

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...

Add Yahoo as a preferred source to see more of our stories on Google. A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers and ...

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 ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen ...