Left atrial appendage (LAA) occlusion procedures are designed to reduce the risk of thromboembolism in patients who have non-valvular atrial fibrillation, but a study presented at the 2023 Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco demonstrated that about half of patients continue to have LAA leaks – and potentially the risk of dangerous blood clots and stroke – a year after the procedure. Read More
The EU approved the first drug-coated balloon for treatment of in-stent restenosis nearly a decade ago, but U.S. physicians continue to have their hands tied in treating the fairly common problem. Results from Boston Scientific Corp.’s investigational device exemption trial for its Agent paclitaxel-coated balloon presented in San Francisco at Transcatheter Cardiovascular Therapeutics could finally put the tool in the hands of cardiologists. The device demonstrated a nearly 50% reduction in the risk of target lesion revascularization and target vessel myocardial infarction compared to conventional balloon angioplasty. Read More
Sofinnova Partners hauled in $200 million in investment for its digital health fund as investors’ appetite for companies developing solutions for health care using digital technology continues to grow. Read More
Virtually all regulatory systems present at least some ambiguity as to the respective regulatory status of software when installed in hardware for medical purposes, and the European Commission’s (EC’s) Medical Device Coordination Group (MDCG) has attempted to provide clarity on these questions. Read More
The U.K. National Institute for Health and Care Excellence (NICE) is offering provisional coverage for digital health technologies for specialist weight-management services as part of its early value assessment (EVA) series. Read More
Cognito Therapeutics Inc. is seeking patent protection for methods for measuring parameters, particularly gamma waveforms, of neurological disorders including neurodevelopmental disorders, psychiatric disorders, and neurodegenerative disorders.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Amra Medical, Angle, EBR Systems. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alphatec, Avallano, Avelo, Bittium, Blink, Centinel Spine, Elligo, Ibex Medical, Myriad Genetics, Nasaclip, Qiagen, Resmed, Roche, Sourcemark, Vivolta. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Concordance Medical, Edwards Lifesciences, Enterra Medical, Eosolutions, Jinghao Medical. Read More
