The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Boston Scientific, Braintale, Catalyst, Life Spine, Stimdia.
The administration of President Joseph Biden announced March 17 a $10 billion allocation of funds for testing to reopen schools in the final months of the current school year, a source of revenues that was provided by the recently passed $1.9 trillion American Rescue Plan. The news follows by one day a new FDA policy on screening tests that allows test developers to distribute tests designed to screen those who are asymptomatic without first validating the test for this use, although there are still questions as to whether this new push will yet again crimp vital testing supplies.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptamer, Belmont Medical Technologies, Bioiq, Cytosorbents, Diamir, Emulate, Interpace, GE Healthcare, Leinco, Magventure, Mologic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA sets up webpage, template for screening; Stryker’s STAR ankle exhibiting fracture risk.
LONDON – Exevir Bio NV added a further €15 million (US$17.9 million) to close its series A round at €42 million, providing the means to take its nanobody therapy for treating COVID-19 infection through to registration.
Roche Holding AG will acquire Genmark Diagnostics Inc. for $24.05 per share in cash for a total of $1.8 billion on a fully diluted basis. The transaction will give Basel, Switzerland-based Roche access to Genmark’s molecular diagnostics portfolio. The deal is expected to close in the second quarter of 2021. The price represents a 43% premium on the Carlsbad, Calif.-headquartered diagnostics company’s share price as of Feb. 10, prior to media speculation about a potential acquisition.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Fujifilm, Olympus Medical, Pelican Diagnostics.
