The U.S. FDA posted an Aug. 6 early alert regarding the use of the Watchman left atrial appendage device by Boston Scientific Corp., citing instances in which the device’s delivery system is associated with events of embolism.

Just two days after reporting the appointment of a new CEO, Instylla Inc. said it received a premarket approval from the U.S. FDA for its flagship product Embrace hydrogel embolic system. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries.

A management-led syndicate of prominent investors acquired a majority stake in Histosonics Inc. that values the company at approximately $2.25 billion. The funding will support expansion of the Edison Histotripsy system and therapy platform into new clinical indications and markets. Edison uses non-invasive focused ultrasound energy to destroy tumors.

The U.S. Federal Trade Commission (FTC) reported Aug. 6 that it will try to block Edwards Lifesciences Corp.’s proposed acquisition of Jenavalve because Edwards’ acquisition of both Jenavalve Technology Inc. and JC Medical would eliminate competition in the TAVR space for aortic regurgitation.

With half-year industry financings down 59% from last year, and a U.S. administration supportive of cryptocurrencies, biopharma companies are building treasuries of digital assets to secure future R&D efforts and operational runways. Companies such as Artelo Biosciences Inc., MEI Pharma Inc., Windtree Therapeutics Inc. and 180 Life Sciences Corp. and have entered crypto deals in recent weeks, with the latter noting the potential to “unlock value outside traditional biotech milestones.”

Bio-Techne Corp. plans to sell its Exosome Diagnostics Inc. business to Mdxhealth SA for $15 million plus royalty payments, a steep cut from the $250 million the company paid to acquire Exodx in 2018. Mdxhealth estimates the unit will generate $20 million in revenue in 2026.

The U.S. Department of Health and Human Services has tapped Sean Keveney for the job of FDA chief counsel, but the recent history of the position muddies the waters when it comes to HHS oversight of FDA legal affairs.

The U.S. FDA has staked out a position on the use of per- and polyfluoroalkyl substances in medical devices, declaring that the evidence offers no reason to restrict their continued use in med-tech products.

Alcon AG agreed to acquire Staar Surgical Co. in a $1.5 billion cash transaction that would add Staar’s Evo implantable Collamer lenses (ICL) to treat myopia to the vision giant’s portfolio. Alcon will pay $28 per share, a 59% premium on Staar’s 90-day volume-weighted average price and a 51% premium on the Aug. 4 closing price of its shares (Nasdaq: STAA).

The U.S. Centers for Medicare & Medicaid Services adopted several significant policy changes in the Medicare inpatient final rule for fiscal 2026, which includes a larger rate bump for hospitals than seen in the draft.