The pivotal ADVENT trial of the Farapulse pulsed field ablation (PFA) system developed by Boston Scientific Corp. returned positive results at one year, according to a presentation at the ESC Congress 2023 that was simultaneously published in the New England Journal of Medicine. The study compared Farapulse, a nonthermal treatment that ablates heart tissue, to radiofrequency or cryoablation, the current standards of care for paroxysmal atrial fibrillation. Read More
The German med-tech associations Bvmed and VDGH have hit out at the shortcomings of the EU medical device regulations and are calling for action to improve implementation, predictability and transparency of the system. Read More
Researchers have created an artificial intelligence (AI)-enabled implantable bio-sensing device that can change shape and adapt to maintain drug treatment and bypass scar tissue build up. As the foreign body response continues to impact the longevity of implantable medical devices that treat many conditions, the researchers hope that the Fibrosensing Dynamic Soft Reservoir (FSDSR), capable of monitoring fibrotic capsule formation and overcoming its effects via soft robotic actuations, can change the way patients body respond to therapeutic treatments. Read More
Magassist Co. Ltd. has been granted a breakthrough device designation by the U.S. FDA for its interventional ventricular assist device (VAD), which is expected to accelerate the development and approval of the product. Read More
Four months after raising $55 million, Magenta Medical Ltd. reported the completion of enrollment to a U.S. FDA-approved early feasibility study with the Elevate percutaneous left ventricular assist device (pLVAD).
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cue Health, Heartvista, Hekabio, Vista.ai. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rapid Medical. Read More
