The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

Generative AI chatbot for doctors called 'Prof. Valmed' earns E.U. approval. In the U.S., FDA is yet to issue guidelines on ...

A new Netflix documentary – The Bleeding Edge – highlights a wide range of systemic flaws in the FDA’s regulation of medical devices. As always, the patient stories are truly heartbreaking ...

Yale researchers discover loophole in FDA medical device regulation. Researchers at the Yale School of Medicine and Harvard Medical School found that a loophole in existing regulation has allowed ...

For the former guidance, the FDA stresses that some device accessories can have lower risk profiles than their parent devices, which would warrant regulation in a lower class.

Dr. Amy Reed, an anesthesiologist and patient-safety advocate, died in May 2017 after a four-year battle with leiomyosarcoma of the uterus. The cancer was spread by a power morcellator, the ...

The new final guidance - which follows similar draft guidance the FDA issued in June 2013 - is part of the agency's overall efforts to improve the cybersecurity of medical devices. Last week, the FDA ...

In February, Biosense Technologies made a splash when it unveiled uChek, a mobile application and companion kit that lets people use their phone cameras to read subtle color differences on urine ...

Onward Medical announced today that it submitted its ARC-EX system for expanded FDA indication and for CE mark approval.

An FDA official clarified, however, that electronic health record systems are not considered MDDS. Read the news release about the new medical device data system regulation . Related Articles on ...