Mark McCarty

The U.S. FDA’s new draft guidance for the voluntary incorporation of patient preference information (PPI) in device development says that PPI would be included in product labels for cleared or approved medical devices.

The U.S. FDA has had its sights on artificial intelligence (AI) for some time, but an upcoming advisory hearing will review questions such as the regulatory status of a generative AI (GenAI) algorithm. This is just one of several AI-related dilemmas facing the agency in the next few years.

The U.S. Government Accountability Office(GAO) has rejected an appeal by MCI Diagnostics Inc. regarding a contract bid with the Department of Veterans Affairs (VA) despite the company’s assertion that the VA pricing mechanism is flawed, an outcome which demonstrates the hazard of making bids that fall outside of VA’s prescribed price ranges.

Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.

The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.

Abstract ideas are not generally eligible for patents in the U.S., but a recent dispute heard by the U.S. Patent Trial and Appeal Board adds a new twist to the question.

The European Commission posted the results of the latest survey of notified bodies, and as the saying goes, there’s good news and bad news.

Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.

Eko Health Inc. recently won a category III CPT code for its Sensora platform for cardiovascular disease detection. While a “cat III” CPT code hasn’t traditionally excited industry, the company is convinced that payers will respond because of the massive costs associated with cardiovascular disease.

Makers of devices and diagnostics face a new set of policy questions following the 2024 U.S. general elections, but many of the impending changes at the executive branch seem directed more toward drugs and vaccines, seemingly leaving the device and diagnostics industries largely out of harm’s way.