• California: Last month, 23andMe laid off around 40% of its workforce, or 200 employees, and said it would discontinue further development of all its therapies as part of a restructuring program. "We are taking these difficult but necessary actions as we restructure 23andMe and focus on the long-term success of our core consumer business and research partnerships," said CEO Anne Wojcicki. 23andMe leadership says the company is currently evaluating strategic alternatives for the therapies that are in development, including licensing agreements and asset sales. After the restructuring plan, 23andMe expects to save an annual cost of over $35 million. (Reuters/CNN, 11/11)
• District of Columbia: Rep. Nancy Pelosi (D-Calif.) was hospitalized after sustaining an injury during an official engagement in Luxembourg. According to the Associated Press, Pelosi was in Europe to commemorate the 80th anniversary of the Battle of the Bulge in World War II. An individual familiar with the situation Pelosi tripped and fell after a group photo with lawmakers and other officials. On Saturday, Pelosi's spokesperson Ian Krager announced that she had underwent hip replacement following her hospitalization. The surgery was "successful," and Pelosi "is well on the mend," Krager said. In a statement, Krager said Pelosi "is grateful to U.S. military staff at Landstuhl Regional Medical Center at Landstuhl Army Base and medical staff at Hospital Kirchberg in Luxembourg for their excellent care and kindness" and that she "is enjoying the overwhelming outpouring of prayers and well wishes and is ever determined to ensure access to quality health care for all Americans." (Jalonick, Associated Press, 12/13; Wise/Andrews, Wall Street Journal, 12/13; Grayer, CNN, 12/13; Sentner, Politico, 12/14)
• Maryland: FDA on Tuesday finalized new guidelines designed to simplify the approval process for medical devices that use AI. Under the guidelines, which were initially proposed in April 2023, manufacturers can seek approval to make changes to their AI-powered products without having to file a new submission showing their safety and efficacy. Manufacturers will submit their plans to FDA, along with a marketing approval application that explains any modifications that will be made and how the changes will be evaluated. "This guidance is intended to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices," FDA said. However, Axios noted that the guidelines are recommendations and not requirements that can be legally enforced. (Goldman, Axios, 12/4)

As demand and margin pressures increase, health systems are looking to technology for solutions. Find out why leading organizations are using software, not hardware, to address surgery-specific problems and enhance clinical decision-making.