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.

Spectrawave Inc. surfed to a $50 million haul in its series B fundraising round for its Hypervue intravascular imaging system. The company appears to have captured the attention of at least one strategic investor, as Johnson & Johnson Innovation-JJDC Inc. led the round.

Data from the Drai Martini study shows that artificial intelligence is shaking up the analysis of electrocardiograms. Results presented at the recent ESC Congress 2024, demonstrated that an AI algorithm, Deeprhythmai, developed by Medicalgorithmics Sp zo.o., has significantly higher sensitivity than human specialists in detecting heart rhythm disorders on long ECG recordings.

Johnson & Johnson subsumed five of its medical technology business under the Johnson & Johnson Medtech name. Ethicon, Depuy Synthes, Biosense Webster, Abiomed and Cerenovus no longer exist as independent entities, but J&J announced no changes in the product lineup.

Brightflow SAS raised €16.5 million (US$18 million) in a series A financing round that will go towards developing its right ventricular mechanical circulatory support system. The company is working towards bringing the first long-term fully percutaneous implantable pump for right-sided heart failure to the market, Sophie Humbert, CEO at Brightflow, told BioWorld.