Medtronic plc kicked off an app-based research study to improve understanding of atrial fibrillation (AF) disease burden and its impact on patient outcomes, quality of life and health care utilization. The first patients in the DEFINE AFib study were enrolled at Duke University Medical Center and the Florida Electrophysiology Associates in Atlantis, Fla. “When it comes to managing atrial fibrillation, there is not a ‘one-size-fits-all’ approach, and the hope is that DEFINE AFib may give us the tools to help personalize AF management based on a patient’s individual health profile and physiology,” said Jonathan Paul Piccini, director of cardiac electrophysiology and associate professor of medicine at Duke University School of Medicine and chair of the DEFINE AFib Steering Committee. “DEFINE AF will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients.” Read More
LONDON – Moves to expand the legal remit of the European Medicines Agency (EMA) and give it more powers to deal with the COVID-19 pandemic and future health emergencies are moving to fruition, after the European Parliament and national health ministers in the European Council separately voted through the proposal. Read More
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date. Read More
The Medicare inpatient draft for fiscal 2022 reflects the effects of the COVID-19 pandemic on claims data for a large number of devices, including those that received additional reimbursement under the new technology add-on payment (NTAP) program. Device makers are urging CMS to add a second year of extension to those NTAP payments, however, a proposal which if adopted would give the affected device makers additional time to recoup their investments. Read More
A study presented this week at the European Society of Human Reproduction and Embryology (ESHRE) annual conference demonstrated that the noninvasive artificial intelligence (AI) technology developed by Aivf Ltd. can instantly differentiate between genetically normal and abnormal human embryos, increasing the likelihood of successful pregnancy for couples using in vitro fertilization. Read More
Med-tech firms raising money in public or private financings, including: Biot Medical, Biovaxys Technology, Boston Therapeutics, Element Biosciences, G Medical Innovations Holdings, Nanomix. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Medtronic, Paragonix Technologies, Pear Therapeutics, Soundbite Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Accelerator Applications, Avacta, Avicenna.AI, B. Braun, Bioivt, Cancer Targeted Technology, Cognetivity Neurosciences, Ethicon, Medline Industries, Merck, Neuroloop, Novacyt, Nuance, Orthofix Medical, Qiagen, Teleflex, Valley Biomedical Products & Services, Verogen. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Attana, Front Line Medical, Galderma, Neuros Medical. Read More
