After a five-year partnership, Senseonics Holdings Inc. and Ascensia Diabetes Care Holdings AG, a unit of Tokyo-based PHC Holdings Corp., agreed to transition worldwide commercialization and distribution of Senseonics’ Eversense 365 implantable continuous glucose monitor back to Senseonics beginning on Jan. 1, 2026.

Sometimes little things can create big problems, which seems to be the case with the recall of the power unit used with the Abbott Heartmate 3 left ventricular assist device (LVAD). According to the FDA recall announcement, the power cords used with the power supply might not stay fixed in place, which would leave the power supply with 15 minutes of backup battery runtime before depletion.

Medtronic plc reported that its soon-to-be spun out diabetes business scored two key regulatory wins.

Edwards Lifesciences Corp. execs no doubt danced a little jig on the release of the latest European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines for valvular heart disease. The update established a simplified pathway for severe aortic stenosis (AS) that eliminated the previous divide between symptomatic and asymptomatic severe AS.

Medtronic plc received U.S. FDA approval for the expanded redo TAVR indication of the Evolut transcatheter aortic valve replacement system. The approval allows for valve-in-valve implantation of a new Evolut valve inside a failed previously implanted TAV made by any manufacturer in patients with severe aortic stenosis considered high-risk for open-heart surgery.

Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.

Medtronic plc posted nearly 50% year-over-year growth in its cardiac ablation business this quarter, with a 72% increase in revenue in the U.S., largely driven by pulsed field ablation. With significant opportunity in renal denervation and a new committee to look at growth including M&A and divestitures and another to review operations, analysts think the company stands a good chance of shedding its “chronic underperformer” image.

Neuroone Medical Technologies Corp. expanded into treatment of chronic pain with a new U.S. FDA clearance for use of its Onerf system to treat trigeminal nerve pain. The system uses radiofrequency ablation to disrupt pain signals from the nerve to the brain.

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.

The U.S. Court of Appeals for the Federal Circuit recently returned a decision in a case pitting Shockwave Medical Inc. against Cardiovascular Systems Inc. in a decision that adds a new wrinkle to the question of how prior art can and cannot be used to eviscerate a patent.