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 ...

Uncovering the dangers associated with a common surgical tool poses a question: Why is the FDA still following a 1976 process that systematically approves devices based on similarity to other devices ...

The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not operate this way; it is built to evolve.

From 2007 through 2017, 98.1 percent of recalled foot and ankle devices had approved through the FDA 510(k) premarket approval, according to a study published in the Cureus Journal of Medical Science.

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation 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 ...

PMA, and DeNovo submissions to bring medical devices to the US market. Recent 510(k) modifications for new technologies and safety advancements, along with AI integration, present significant ...

FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...

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 ...

Belfast-based Neurovalens has been granted medical device De Novo approval from the US Food & Drug Administration (FDA) for Modius Lean, its prescribed treatment for weight management. Neurovalens is ...