Initiated Nationwide Commercial Launch of AYON in SeptemberThe Company is Hosting a Virtual Key Opinion Leader Event to Discuss the Commercial ...

The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real ...

The U.S. Food and Drug Administration (FDA) this week approved a new abortion pill made by a company that explicitly says it seeks to “normalize” abortion. A Sept. 30 letter obtained from the office ...

With a government shutdown now in effect, the U.S. FDA—already shaken up by head count reductions earlier this year—has sought to keep many of its functions running for the foreseeable future. But the ...

The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its request for comment, factors such as changes ...

Comments are due Oct. 27 to the Office of Science and Technology Policy on federal regulations that hinder artificial intelligence development, deployment or… An AHA blog published today shares how ...

The FDA has expanded its Early Alert program to give the healthcare industry earlier visibility into potential high-risk medical device issues. The agency’s Center for Devices and Radiological Health ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

The Food and Drug Administration has rescinded its final rule on laboratory developed tests, formally ending a decades-long effort to expand oversight of the lab industry. The FDA issued a new final ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Many blood pressure (BP) measuring devices do not have FDA marketing authorization and can't be relied upon, the agency said in a safety communication. "Do not use unauthorized blood pressure devices, ...