The FDA’s device center has revisited the 2005 guidance for the content of premarket submissions for device software functions, a document that puts much more emphasis on risk compared to the legacy 2005 guidance.

U.S. President Joe Biden on Nov. 12 announced his intent to nominate former FDA Commissioner Robert Califf to return to the regulator’s top job. He would take the place of Janet Woodcock, acting commissioner of the agency since Jan. 20.

When the U.S. Congress resumes next week, its top priority will be the passage of a massive budget bill that once again includes long-promised – or threatened, depending on a person’s perspective – provisions intended to bring down prescription drug prices.

The U.S. NIH said it will go to court if necessary to defend its role in developing Moderna Inc.’s COVID-19 vaccine. NIH spokeswoman Renate Myles told BioWorld that the agency “is not giving up on our claim that NIH is a co-inventor on the mRNA technology used in the Moderna’s COVID-19 vaccine but defers to legal authorities on how this might be resolved.”

Ultrasound companies, Caption Health Inc. and Ultromics Ltd. are linking up to jointly offer Caption’s AI software platform with Ultromics’ Echogo deep ultrasound analytics for cardiovascular disease detection.

Entities that lack experience in FDA regulation of medical devices may find the going both expensive and time consuming, but there are resources available to these players in the digital health space. Bakul Patel, director of the Digital Health Center of Excellence at the FDA’s device center, said that while he understands that reading through agency guidance is an unpleasant task, the companies that take the time to do so may find their interactions with the agency less iterative and more productive, thus speeding their path to market.

Arthrex Inc., of Naples, Fla., is well known for lobbing a legal hand grenade into the inter partes review (IPR) process for patent disputes, but the company is now drawing ink for a different legal reason. According to the U.S. Department of Justice (DoJ), Arthrex has agreed to pay $16 million to settle allegations that it engaged in kickbacks to a surgeon, payments ostensibly made to pay for assistance with device design, but which the DoJ claims were intended to induce the surgeon’s use and endorsement of Arthrex products.

The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the proposal to provide automatic Medicare coverage of FDA breakthrough devices, but the proposal may not be as dead as it once seemed.