Meril Life Sciences Pvt Ltd. recently launched its next generation transcatheter heart valve (THV), the Myval Octapro THV, which it says allows for better operator control for precise positioning and improved predictability in implantation. The new valve comes however, as the company battles with Edwards Lifesciences Corp. in a European court over patent infringement of its technology.

Although there is a clear clinical need for transcatheter mitral valve replacement technologies, a number of challenges must be overcome before they can safely be used to treat patients with mitral regurgitation. Nevertheless, two new devices could enter the European market next year, Edwards Lifesciences Corp.’s Sapien M3 and Highlife Medical SAS’s Highlife TMVR device.

Edwards Lifesciences Corp. revealed excellent one-year data highlighting the performance of its newest generation Sapien 3 Ultra Resilia valve. Patients treated with the transcatheter aortic valve replacement system experienced lower rates of mortality and reintervention compared to its predecessors.

Ultromics Ltd. received clearance from the U.S. FDA for Echogo Amyloidosis, its artificial intelligence-enhanced software that helps with the early diagnosis of cardiac amyloidosis, enabling timely intervention that can significantly improve patients' quality of life and extend survival.

The U.S. FDA granted Brightheart SAS 510(k) clearance for its artificial intelligence software which helps doctors detect congenital heart defects in fetuses. The software will transform prenatal ultrasound evaluations of the fetal heart and improve the outcomes for newborns, Cécile Dupont, Brightheart’s CEO, told BioWorld.

The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.

The U.K. Secretary of State for Health and Social Care, Wes Streeting, says that he wants people to see the national health service as a neighborhood health service as he works towards reimagining the health system and bringing care into people's homes. Data, he said, will be at the heart of the transformation. So too will be the deployment of science and medical technologies.

Investors and corporates in health care are optimistic going into 2025 as they believe that capital constraints in the sector are finally easing, according to a report by global investment bank Jefferies. The return of the IPO market and increased M&A activity contributed to an uptick in confidence in the sector.

Smartcardia SA received U.S. FDA clearance for mobile outpatient cardiac telemetry for its seven-lead live ECG monitoring patch and cloud platform. With the approval, the solution can now be used for remote live monitoring of a patient’s ECG and immediately notify clinicians in cases of arrhythmias.

Medtronic plc obtained a CE mark for its next generation Endoflip 300 system which measures pressure and dimensions in the esophagus and pylorus, in adults. The Endoflip can be used to help diagnose and treat thousands of people across Europe suffering with esophageal motility disorders.