Vivasure Medical Ltd. received CE mark approval for its Perqseal Elite vascular closure system which manages bleeding complications associated with large-bore arterial vessel closure. The sutureless, fully bioresorbable device has the potential to reduce problems associated with traditional closure methods in patients undergoing complex structural heart procedures.

The Heart Rhythm Society and American College of Cardiology published guidance for same-day discharge of cardiac ablation patients during Heart Rhythm 2025, the society’s annual meeting, which was held in San Diego April 26-27.

Using step counts and heart rate readings from Google’s Fitbit devices, a machine learning model accurately predicted the risk of hospitalization, a study presented at Heart Rhythm 2025 found. The study used data from participants in the National Institutes of Health’s All of Us research program.

Growth in the first quarter for Boston Scientific Corp.’s blockbuster products, Farapulse and Watchman, pushed the company well over analysts’ expectations and gave management confidence to raise its guidance for the year to 15% to 17% up from 12.4% to 14.5%, despite a projected $200 million in tariff impacts.

AMT Medical BV raised $25 million in a series B financing round for its Excimer Laser Assisted Non-Occlusive Anastomosis heart bypass system. The funds will go towards clinical trials and regulatory approval for its sutureless coronary bypass technology designed to replace traditional open-heart bypass surgery.

Field Medical Inc. reaped $40 million in its series A fundraising via $20 million in new capital and conversion of $20 million in seed-round debt to support development of its next-generation pulsed field ablation technology. Field Medical’s Fieldforce ablation system targets ventricular tachycardia as its initial use, but also has a study in process for atrial fibrillation.

Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.

Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.

Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.

The U.S. Medicare draft inpatient rule for fiscal 2026 discusses a number of coding proposals, although the agency seems disinclined to go along with a proposal to increase payment rates for TAVR devices by switching the procedures to a different diagnostic-related group.