Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal. Read More
Rapid Medical Ltd.'s journey took a promising turn with a U.S. FDA clearance of Drivewire, the company's steerable guidewire for neuro and peripheral vasculature. Drivewire allows surgeons to adjust the shape of the tip while traversing challenging vasculature. It is the first neurovascular guidewire with a controllable distal end that permits on-demand course and shape changes during a procedure. Read More
The U.S. FDA has exercised a considerable degree of enforcement discretion during the COVID-19 pandemic, particularly when it comes to digital health. However, Christine Bump, principal at Penn Avenue Law & Policy, said that this very discretion has an uncertain shelf life and advised industry to remain compliant with the regulations as much as possible to avoid unnecessary enforcement actions by federal agencies. Read More
TORONTO – It took the Vancouver, British Columbia-based biotech three times, but before the week in mid-December was over, Abcellera Biologics Inc. had finally closed its IPO on the Nasdaq, hoovering up gross proceeds of $555.5 million. Read More
PERTH, Australia – Australia is employing some new genomic tools to help identify SARS-CoV-2 infections and track them within communities. Illumina Inc. and the University of Melbourne have partnered to establish the Illumina-University of Melbourne Genomics Hub – a first for the Asia-Pacific region – which will bring together the best of genomic expertise and technology in Australia. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amoy Diagnostics, Aytu Bioscience, Concord Healthcare Singapore, Corning, Eurofins Genomics, Merck KGaA, Olympus Partners, Soterix Medical, Titan Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mologic. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS unveils push toward digital collection of quality measures; NIH awards for ‘outside-the-box’ projects under RADx; ISO posts IP management standard. Read More
Keeping you up to date on recent developments in cardiology, including: Differences seen between the sexes in terms of stroke survival; Light used to control cardiac waves; 3D-printed blood vessels ID possible link between coronavirus, stroke. Read More
