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.

Cereno Scientific AB’s positive top-line results from the phase IIa trial of histone deacetylase inhibitor CS1 in pulmonary arterial hypertension provide a “clear path forward” in the debilitating, fatal disease, the company said.

The Pi-Cardia Ltd. Shortcut — the catheter-based, leaflet modification solution for treating heart valves — received U.S. FDA clearance. The device was granted breakthrough device designation from the regulatory agency and is designed to split bioprosthetic aortic valve leaflets in patients undergoing valve-in-valve transcatheter aortic valve replacement (TAVR) procedures who are at risk of coronary obstruction.

Route 92 Medical Inc. sped past its series F goal, raising an additional $50 million in an extension to the oversubscribed round. The extension brings the total for the series F to $82 million, which the company plans to use to accelerate commercialization of its neurovascular reperfusion and access systems.

Researchers from UCLA’s Department of Cardiac Surgery filed for protection of a smart multistage peripherally inserted cannula with active fixation for temporary cardiopulmonary support which simultaneously drains both sides of the heart.

Merit Medical Systems Inc. reported it is buying the lead management assets of Cook Medical Inc. for $210 million in cash. The Cook products consist of lead extraction devices and other lead management products.

The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.

Researchers at Klick Labs Inc. reported using a person’s voice to predict chronic hypertension with a high degree of accuracy. Data published in IEEE Access, found the potential for advancing early detection of chronic high blood pressure, showcasing another novel way to harness vocal biomarkers for better health outcomes.