Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...

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

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

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

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.

Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...

The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...

Computerized Maintenance Management System (CMMS) software can be a vital tool for life sciences manufacturers in maintaining ...

The United States is currently under the spotlight as Donald Trump’s recent appointment and consequent nomination of Robert F ...

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.

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