Emitbio Inc., a life science company developing light-based therapies, is seeking emergency use authorization (EUA) from the U.S. FDA for its investigational device to treat mild to moderate COVID-19 infection at home. The portable, hand-held device works by directing precise wavelengths of visible light to the back of the throat and surrounding tissues. It is not yet available for sale in the U.S.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Clearpoint Neuro, Exem Foam, Healthmode, Mindmed, New Horizon Health, Philips, Viewpoint Molecular Targeting.
The U.S. NIH’s Feb. 17 announcement that it’s funding a study of the effects of remdesivir in treating COVID-19 in pregnant women is welcome news, but it begs the question of why it took so long given the risk of more severe disease in that population.
Just months after a modest IPO, shares of Immunome Inc. (NASDAQ:IMNM) climbed 75.6% on Feb. 18, closing at $39.01. Driving the momentum was an announcement that pseudovirus testing indicates that its antibody cocktail, IMM-BCP-001, appears capable of neutralizing several SARS-CoV-2 variants, an emerging challenge to currently available vaccines and pandemic management efforts.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS commits more funds for testing, materials to fight pandemic; Medtronic announces recall of Valiant Navion; Florida man pleads guilty in DME fraud.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Delta International Services & Logistics, Everlywell, Horiba Medical, Thermo Fisher Scientific, Vax-Immune Diagnostics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anaconda Biomed, Catalyst Orthoscience, Genmark Diagnostics, Vocalis Health.
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