The final Medicare coverage memo for transcatheter edge-to-edge repair for tricuspid valve regurgitation largely replicates the April 2025 draft, but cardiology centers will not have to bring an electrophysiologist to the patient’s care team to be permitted to practice these devices.
Kardium Inc. raised C$340 million (US$250 million) in an oversubscribed financing round to support commercialization of its Globe pulsed field ablation system for atrial fibrillation. Notably, the financing included an equity investment by an unnamed leading strategic investor. Kardium could receive U.S. FDA approval as early as this quarter and plans to launch Globe in the U.S. this year.
Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in critically ill patients in intensive care units (ICU). The company said the Vitalflow ECMO system represents a ‘new paradigm’ in ECMO therapy as it is designed to simplify ICU operations and brings performance, ease of use and adaptability to the forefront of patient care.
Aortic valve repair and replacement continue to grab attention appropriate for the number of people affected, but the heart’s other three valves are finally gaining some respect as med-tech companies and analysts recognize the size of the potential total addressable market.
Deski SAS raised $6 million in a seed round to support the launch of its cardiac imaging software, Heartfocus, in the U.S. The AI-driven heart exam tool helps health care professionals perform echocardiograms from any ultrasound probe to enable the early detection of heart disease.
Chinese researchers are preparing the details for the publication of another scientific milestone, the creation of a chimera with a human heart and a kidney developed from human stem cells in pig embryos.
Two med-tech companies focused on pulmonary embolism overcame their own blockages to commercialization this week. Inquis Medical Inc.’s Aventus thrombectomy system received U.S. FDA clearance for use in pulmonary embolism, an expanded indication, while Penumbra Inc. completed enrollment in the STORM-PE clinical trial of its Lightning Flash device.
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
Medicare Advantage plans have been controversial for several reasons, and the Advanced Medical Technology Association has now made the argument that the Centers for Medicare & Medicaid Services should require these plans to replicate the terms of the Medicare new technology add-on program.
Aortyx SL secured €13.8 million (US$15.9 million) in a series A funding round for its solution which treats aortic dissection. The company developed a system to repair the aortic tear, which includes a biomimetic, bioresorbable adhesive patch inserted in the aorta using an endovascular catheter and a deployer.