The FDA reported several class I recalls in the first week of September 2024, a list that includes products such as Medtronic plc’s McGrath line of laryngoscopes, some of which should be jettisoned.
Elixir Medical Corp. reported positive 12-month data from the Infinity-Swedeheart trial that compared its Dynamx coronary bioadaptor system to Medtronic plc’s Resolute Onyx zotarolimus drug-eluting stent in patients requiring percutaneous coronary intervention with coronary artery disease.
Abbott Laboratories’ diabetes unit opened the month with a two-cannon salvo – a partnership with Beta Bionics Inc. that will integrate Abbott’s Freestyle Libre 3 Plus continuous glucose monitor with the Ilet Bionic Pancreas system and the roll out of its over-the-counter Lingo CGM in the U.S.
Boston Scientific Corp. obtained a CE mark for its latest self-expanding transcatheter aortic valve replacement technology, the Acurate Prime, opening up a new access point for increased sales and profitability in its structural heart division this year.
Since the U.S. FDA’s approval of the first pulsed field ablation (PFA) system in the U.S. last December, PFA technology has rapidly reconfigured the electrophysiology market in the U.S. and ramped up sales of PFA systems in Europe.
Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.
Medtronic plc hit a sweet spot with its diabetes devices, with the unit leading the company in growth in its first quarter 2025 results. Diabetes device sales grew 11.8% to $647 million for the quarter, an important boost that pushed total revenue up to $7.9 billion ($8.01 billion, adjusted), a 2.8% reported increase or 5.3% exchange rate impact. No other unit saw more than single-digit increases in sales.
The U.S. FDA recently granted Medtronic plc approval for its deep brain stimulation (DBS) system to be used to treat Parkinson’s disease or essential tremor while a patient is asleep, under general anesthesia. The approval gives patients another option for DBS therapy which can transform their quality of life, Amaza Reitmeier, vice president and general manager for Medtronic brain modulation, told BioWorld in an interview.
Andera Partners involvement in a string of recent deals in the cardiovascular space demonstrates the ongoing appetite for devices to treat heart diseases, Olivier Litzka, a partner at Andera Partners told BioWorld.
There is no evidence to support the differences in prices that the U.K.’s national health service (NHS) is paying for transcatheter heart valves from Abbott Laboratories, Boston Scientific Corp., Edwards Lifesciences Corp. and Medtronic plc, according to the National Institute for Health and Care Excellence.
