Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.

After nearly two years with an acting director, the U.S. NIH now has a confirmed leader. The Senate voted 62-36 Nov. 7 to confirm Monica Bertagnolli, a cancer surgeon and researcher, as the next director of the research agency.

The U.S. Centers for Medicare & Medicaid Services has followed through on an earlier threat to reduce payments for various sorts of radiology services in the physician fee schedule, including those invoked during episodes of cancer care, but Congress may yet intervene.

Privacy considerations have been front and center for U.S. federal government agencies for more than two decades, but several states have jumped into the privacy arena with their own legislative imperatives. While companies in the medical device industry would like to see a less imposing thicket of related enforcement requirements, Nancy Perkins of Arnold & Porter LLP said there is little prospect that Congress will relieve the predicament with anything resembles preemptive legislation.

The U.S. Department of Justice (DOJ) has a unique role in enforcement of medical product communication even though the department shares oversight of medical product promotions with the FDA and the Federal Trade Commission (FTC).