Boston Scientific Corp. has exercised an option as part of a 2020 agreement to acquire Farapulse Inc. in full, folding the startup’s pulsed electric field ablation technology for the treatment of atrial fibrillation and other cardiac arrhythmias into its own electrophysiology portfolio. With a 27% stake in Farapulse already, it will pay about $295 million for the remainder. Read More
The FDA’s device center recently updated its guidance for testing and labeling of devices for compatibility with magnetic resonance (MR) fields. Some items, such as orthopedic plates and screws, might not have been evaluated for compatibility up to now. The FDA’s Sunder Rajan said that existing 510(k) and PMA devices are grandfathered in under the legacy policy, but that all implants will have to be evaluated for MRI compatibility going forward, even devices not previously subject to testing. Read More
TORONTO – Health Canada has proposed a single regulatory framework for medical device and drug clinical trials after broad industry consultation and a hard line drawn by the COVID-19 pandemic for a more streamlined system. Read More
Pattern Computer Inc.'s test for SARS-CoV-2 infection gives new meaning to rapid results. Taking 15 seconds from start to result, the test offers balanced accuracy of better than 96%, according to the company. The test is also not dependent on timing, unlike current antibody tests, and takes less time than point-of-care PCR tests. Its light-based system creates patterns based on a saliva sample, which is then matched against a previously developed model. Read More
Princeton University spinout Neutigers Inc. is launching a study to explore the use of artificial intelligence (AI) and everyday wearables to flag early symptoms of sickle cell anemia vaso-occlusive crisis (VOC) before they get worse and land patients in the hospital. The aim is to reduce deaths and facilitate interventions to address the entire continuum of care for patients with the inherited red blood cell disorder, Adel Laoui, founder and CEO, told BioWorld. Read More
LONDON – New data from a randomized community study involving more than half a million people has shown that of 92,116 who had symptomatic COVID-19, 38% were still reporting symptoms 12 weeks later. Read More
New hires and promotions in the med-tech industry, including: Artio Medical, Femasys, Motus GI, Neurent Medical, Piccolo Medical, Smisson-Cartledge Biomedical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biomerica, Canon Medical Systems, Cmic, Cutiss, Draper, Haven Testing, Immudex, Invivoscribe, Johnson & Johnson, Lokavant, Medtronic, Merck, Novarad, Nucleai, Omron Healthcare, Penumbra, Rapid AI, Surfacide, United Therapeutics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diabetomics, Oticon Medical, Otolith Labs, Sorrento Therapeutics. Read More
