The U.S FDA approved Camaps FX for use in pregnant women with type 1 diabetes. This first, hybrid, closed-loop app was developed by Camdiab Ltd., a spinout from Cambridge University, allows individuals aged two years and older with type 1 diabetes to manage their glucose levels.

Volta Medical SAS reported positive results from the Tailored-AF study which compared its artificial intelligence software-guided ablation procedure in combination with pulmonary vein isolation to a conventional anatomical ablation targeting PVI alone, to treat persistent atrial fibrillation.

Boston Scientific Corp. is hoping to help change European guidelines on the use of intravascular imaging during percutaneous coronary intervention procedures, Emile Mehanna, medical affairs and medical education director, interventional cardiology, EMEA, told BioWorld.

Nuvo Group Ltd. recently completed a business combination with Los Angeles Media Fund (LAMF) Global Ventures Corp, a special purpose acquisition company, and became a listed company in a bid to bring its Invu pregnancy monitoring and management platform to as many women as possible. “We are totally focused on women's health and trying to drive better outcomes through pregnancy care,” Rice Powell, CEO of Nuvo, told BioWorld.

Elixir Medical Corp. reported positive 12-month clinical data from the Desyne BDS Plus randomized controlled trial which evaluated its Desyne BDS plus system, a triple drug-eluting coronary implant with site-specific antithrombotic therapeutic coating, against a contemporary, durable polymer drug-eluting stent in the treatment of de novo native coronary artery lesions.

One-year data from the Notion-2 trial, which compared transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in younger low-risk patients with severe tricuspid or bicuspid aortic valve stenosis, showed little difference in clinical outcomes between the two procedures. The results were presented at the recent EuroPCR conference in Paris.

Data from Meril Life Sciences Pvt Ltd.’s Landmark trial showed that its series of Myval transcatheter heart valves were non-inferior compared with Edwards Lifesciences Corp.’s Sapien BEV and Medtronic plc’s Evolut SEV devices, with regards to safety and effectiveness in patients undergoing transcatheter aortic valve implantation.

Elixir Medical Corp. revealed that data from the Pinnacle I study has validated the safety and effectiveness of its Lithix Hertz contact intravascular lithotripsy system to treat moderate to severe calcified coronary artery lesions by percutaneous transluminal coronary angioplasty.

There should be no more excuses to the adoption of renal denervation (RDN) as a treatment for hypertension given the recent approval by the U.S. FDA of two technologies and a range of guidelines recommending the therapy, delegates heard at the EuroPCR conference in Paris. In a discussion on the technology, panelists argued that on the back of solid evidence, RDN should be offered as a treatment given that the therapy is a safe method to reduce high blood pressure.

Two-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that there is a significant clinical advantage in using its Dynamx coronary drug-eluting bioadaptor system over Medtronic plc’s Resolute Onyx drug-eluting stent in patients with coronary artery disease.