News We're Watching

This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.

This week, the US FDA sent a warning letter to maker of batteries for AEDs, AMCO; Virtual Incision successfully completed the first hysterectomy its miniaturized robotic-assisted surgery device MIRA; The DOJ finalized a rule that requires government-operated health care facilities to provide accessible equipment for people with disabilities; the FDA compiled its resources on reprocessed medical devices onto a new web page; and more.

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

This week, the ACLA filed a lawsuit against the US FDA; Philips recalled around 100,000 ventilators; women’s health companies Natural Cycles and Gameto padded their coffers; and Canary Medical and J&J’s Ethicon received FDA nods.

This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.