To the surprise of no one in the device industry, the Medicare national coverage analysis for renal denervation (RDN) includes both radiofrequency and ultrasound technologies, but the agency has listed a range of specialists to be part of the patient’s care team, including but not limited to an endocrinologist.
The U.K.’s National Institute for Health and Care Excellence (NICE) recommends the use of pulsed field ablation as an option to treat NHS patients with atrial fibrillation. NICE said evidence shows the procedure reduces atrial fibrillation and its symptoms, increases quality of life in the short term and raises no major safety concerns.
Boston Scientific Corp. gained a second U.S. FDA approval for its Farapulse pulsed field ablation catheter, expanding its use into drug-refractory, symptomatic persistent atrial fibrillation (AF) in addition to its existing approval for paroxysmal AF. The expanded indication marks the first of several regulatory approvals the company expects in the coming months.
Field Medical Inc. continues to reap funding from investors for its pulsed field ablation (PFA) system with a $35 million oversubscribed series B financing round. With treatment of atrial fibrillation already upended by PFA technology, Field sees ventricular tachycardia as a fertile new territory for transformation.
The House of Representatives passed H.R. 1, also known as One Big Beautiful Bill, which will restore personal income tax cuts that expired in 2022. However, the bill also restores research and development tax credits, a provision that drew immediate praise from industry.
Kardium Inc. raised C$340 million (US$250 million) in an oversubscribed financing round to support commercialization of its Globe pulsed field ablation system for atrial fibrillation. Notably, the financing included an equity investment by an unnamed leading strategic investor. Kardium could receive U.S. FDA approval as early as this quarter and plans to launch Globe in the U.S. this year.
Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in critically ill patients in intensive care units (ICU). The company said the Vitalflow ECMO system represents a ‘new paradigm’ in ECMO therapy as it is designed to simplify ICU operations and brings performance, ease of use and adaptability to the forefront of patient care.
The U.S. Centers for Medicare & Medicaid Services posted the draft home health rule for calendar year 2026, which includes a proposal to subject continuous glucose monitors and insulin pumps to competitive bidding, but the agency is also considering a more rapid pace of replacement of these technologies.
The rapid adoption of the Omnipod 5 answered a question automated insulin delivery system manufacturers posed for years: with clear health benefits and payer coverage, why has pump adoption been so slow? Insulet Corp.’s Omnipod 5’s rapid rise to dominance demonstrated unequivocally that people with diabetes want a stick-and-forget device. The American Diabetes Association’s 85th Scientific Sessions in Chicago on June 20-23 made just as clear that pump makers received the message with several companies outlining plans to introduce a patch system in the next two years.
Medtronic plc received U.S. FDA approval for its Omniasecure defibrillation lead for placement in the right ventricle to treat arrhythmias. Medtronic said the lead is the smallest made at 4.7 French or 1.6 mm, making it suitable for individuals as young as age 12 and others with smaller anatomies, particularly women.
