The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Fortress Diagnostics, Lemaitre Vascular, MedPAC.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Color, Labcorp, Rapid Medical, Stratus Medical, Zebra Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atox, Bruker, Cell and Gene Therapy Catapult, Cpi, Healthimation, Masimo, Microfluidx, Nanthealth, Nemaura, OpenNMS, Orcam, Perimeter Medical Imaging, Telix Japan, Transenterix, Wishbone Medical.
Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases.
The question of screening for the COVID-19 pandemic continues to absorb the interest of both the U.S. FDA and test developers, and Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said in a July 22 webinar that the FDA is “very interested” in a fingerstick test at the point of care for screening purposes, adding that the agency sees any such applications as a priority.
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