With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...

Explore the rapid growth of the Indian MedTech industry and the importance of FDA 510(k) clearance for global expansion.

Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...

In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...

You don't need a prescription to purchase a test that will tell you whether you're sick with COVID or the flu.

In a conversation with The Regulatory Review, Ropes & Gray partner David Peloquin discusses how clinical research studies are ...

The FDA’s new requirements represent a fundamental shift in the regulatory landscape for medical device manufacturers (MDMs), as cybersecurity is now a non-negotiable element of device ...

While FDA evaluation of medical devices is based on “reasonable ... have undergone post-approval clinical studies. Without CMS’s requirements or incentivization to conduct clinical utility ...

Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...

Integra LifeSciences Holdings said a subsidiary received a warning letter from the Food and Drug Administration over issues identified during inspections at three company facilities.