Shockwave Medical, a unit of New Brunswick, N.J.-based Johnson & Johnson Medtech, completed enrollment in the first prospective all-female study of percutaneous coronary intervention in complex disease. The real-world, all-comers trial will evaluate the benefits of coronary intravascular lithotripsy in female patients with calcified lesions.

Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.

Boston Scientific Corp. posted another eye-popping quarterly report, led by a 177% year-over-year increase in its electrophysiology business to $527 million, which exceeded consensus expectations by $99 million. That stunning EP growth follows 125% growth in the second quarter and 70% in the first quarter, all largely attributed to the Farapulse pulsed field ablation system, which achieved unprecedented adoption rates.

Boston Scientific Corp. racked up a two-fer from the U.S. FDA with approval of its navigation-enabled Farawave Nav ablation catheter and 510(k) clearance for the Faraview software for use with its Farapulse pulsed field ablation (PFA) system.

Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.

Rhythm AI Ltd recently became the latest company to receive U.S. FDA clearance for its artificial intelligenc-based software for optimizing Atrial Fibrillation procedures.

The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.

Edwards Lifesciences Corp. made a splash recently with the U.S. FDA approval of the Evoque tricuspid valve replacement device, but is also pressing Centers for Medicare and Medicaid Services to provide a coverage framework for this class of devices.

The recent uptick in med-tech deals is a sign technologies that are solving unmet clinical needs are finally coming to fruition, Antoine Papiernik, chairman and managing partner at Sofinnova Partners, told BioWorld in an interview.

Researchers from Johns Hopkins University have filed for protection of their Optimal Target Identification via Modelling of Arrhythmogenesis technology – a method that builds a model of a patient’s heart from a cardiac MRI.