Medtronic plc won expanded FDA 510(k) approval for its Arctic Front family of cardiac cryoablation catheters for alternative treatment of recurrent symptomatic paroxysmal atrial fibrillation (AF) as an alternative to the current standard first-line treatment, antiarrhythmic drug (AAD) therapy. The Arctic Front family of catheters are the first catheter ablation devices in the U.S. approved to help physicians improve AF patient outcomes before drug failure. They have also been proven to shorten the time to diagnosis, according to Dublin-based Medtronic. Read More
In a split decision delivered June 21, the U.S. Supreme Court resolved the dilemma created by the constitutional non-reviewability of decisions rendered by the Patent Trial and Appeal Board (PTAB). The Supreme Court’s solution is to make those PTAB decisions reviewable by the director of the Patent and Trademark Office (PTO), although the PTO director’s discretion regarding which PTAB cases should be reviewed may itself prove highly controversial in the months and years to come. Read More
Cleerly Inc. snapped up $43 million in a series B fundraising round to develop artificial intelligence (AI)-enhanced imaging to better understand heart disease and more accurately project patient outcomes. Vensana Capital led the round with participation from the American College of Cardiology, Cigna Ventures, Dititx Partners, Lrvhealth (formerly Long River Ventures), New Leaf Venture Partners and returning investors. Read More
Shenzhen Mindray Bio-Medical Electronics Co. Ltd. plans to release a couple of new imaging solutions this month as part of continued and rapid growth in its home market and globally. The first to be unveiled by the Shenzhen, China-based company is the Resona I9, its latest general imaging diagnostic ultrasound system. Read More
Paris – Cardinor AS has secured $1.44 million to commercialize development of a novel ELISA (enzyme-linked immunosorbent assay) blood test that uses secretoneurin as a blood-based biomarker for heart disease and sudden cardiac arrest. London-based Intuitive Investments Group plc participated in this third seed round, along with existing Belgium and German investors. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aiforia, Alibaba Health, Anatech, Avacta Group, Berry Oncology, Calibre Scientific, Cancer Diagnostics, Efferent Health, Epredia, Madison Core Laboratories, Paige, Parvizi Surgical Innovation, Predictive Health Diagnostics Company, Raysearch, SHL Telemedicine, VNA Care. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo, Medtronic, Onward Therapeutics, Qualimed, Sensome. Read More
