The force is with Field Medical Inc. as it celebrates the U.S. FDA’s decisions to grant breakthrough device designation (BDD) to its Fieldforce ablation system and to accept it into the agency’s Total Product Life Cycle Advisory Program pilot. Field Medical designed the Fieldforce pulsed field ablation catheter specifically to treat ventricular tachycardia. The BDD applies to its use in monomorphic scar-related VT.

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.

Medtronic plc and Tempus AI Inc. launched the ALERT study to better understand and address the racial, ethnic, gender and geographic disparities associated with guideline-recommended treatments for aortic stenosis and mitral valve regurgitation. Currently, white patients represent 91% of people who receive TAVR procedures, a minimally invasive procedure that sharply reduces complications and improves quality of life in patients with narrowed heart valves.

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.

An international consortium of thousands of scientists is creating the Human Cell Atlas, a three-dimensional map of all the cells in the body. The goal is to understand all the cells that make up human tissues, organs and systems, which will enable multiple medical applications. This collection of cell maps is openly available for navigation at single-cell resolution, identified through omics analyses that reveal the tridimensional distribution of each cell.

Three years after the U.S. FDA approval of Abbott Laboratories’ Amplatzer Amulet, results of its investigational device exemption trial failed to notably differentiate Abbott’s left atrial appendage occluder system from Boston Scientific Corp.’s market-dominant Watchman device beyond the ability to forego anticoagulants quickly after implantation.

Gender bias in cardiac treatment guidelines is putting women at risk because guidelines are written based on clinical trials conducted mostly in men. As previously reported in BioWorld, nearly 70% of female patients are underdiagnosed for cardiovascular disease as women are grossly under-represented in clinical trials.