WHITE BEAR LAKE, Minn. (FOX 9) - A Minnesota-based medical device company is on the verge of transforming how hearing is ...
Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: ...
John Torous, MD, MBI, of Beth Israel Deaconess Medical Center in Boston, added that chatbots must prove they don't lead to ...
The FDA announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to ...
CapsoVision, a medical device developer, submitted an application Nov. 6 to the FDA requesting breakthrough device designation for its CapsoCam UGI capsule, aimed at detecting early-stage pancreatic ...
The U.S. Food and Drug Administration (FDA) is warning consumers, patients and health care providers about the potential risk ...
RF microneedling has become a popular treatment in recent years. "It can effectively reduce the prominence of fine lines, ...
George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory ...
The FDA process is time-consuming and costly. There’s no reason to do it if your product is not going to cross the line," ...
In the home, the lab and the factory, electric fields control technologies such as Kindle displays, medical diagnostic tests ...
The US Food and Drug Administration (FDA) recently issued safety concerns on the use of RF microneedling devices for cosmetic procedures.