Integra Lifesciences Holdings Corp. agreed to acquire Acclarent Inc. from Johnson & Johnson’s Ethicon Inc. subsidiary for $275 million in cash at closing with a further $5 million contingent on achievement of certain regulatory milestones.

Edwards Lifesciences Corp. set analysts a-spin ahead of its investor day activities with the revelation it plans to launch its critical care unit as a stand-alone public company next year. Edwards expects that dividing the business will allow it to focus on cardiovascular and surgical markets.

After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices.

The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.

Dexcom Inc. achieved the first integrations of an automated insulin delivery system (AID) approved for use in the U.S. with its G7 continuous glucose monitoring (CGM) integrating with Tandem Diabetes Care Inc.’s T2:slim X2, announced on Dec. 6, and integration with the Ilet Bionic Pancreas made by Beta Bionics Inc. revealed on Dec. 7.

The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view.

The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.

Intuitive Ventures, the investment arm of Intuitive Surgical Inc., closed a $150 million fundraising round for its second fund, which will focus on investments in startups in three areas: precision diagnostics and interventions, digital ecosystems and improving health care access and coordination. Intuitive Surgical’s first venture fund raised $100 million that has been used to support more than 10 early-stage companies.

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was accorded a mere 60 days for comment, but nonetheless drew support from a number of stakeholders, including Foundation Medicine of Cambridge, Mass.