Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Syntheticmr.
The need for self-administered surveillance testing finally has a few candidates, thanks to labs and test developers across the globe, and the U.S. FDA is keen on exploiting the opening. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the agency’s Sept. 2 testing town hall that the agency is interested in a test intended to be self-administered multiple times compared to a test validated under a single test approach, a flexibility that may prove critical in advancing the U.S. approach to testing for the COVID-19 pandemic.
As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx.
Tissue Regeneration Technologies LLC (TRT) has nabbed U.S. FDA 510(k) clearance of its Orthogold 100 device for the treatment of superficial burns. The patented Softwave technology uses an unfocused extracorporeal shock wave to spur a physical and biological response that aids in wound healing. The FDA cleared the device for the treatment of superficial, partial-thickness, second-degree burns in adults.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biohit, Cardiac Dimensions, Detectachem, Exsomed, Pq Bypass, Tissue Regeneration Technologies.
The U.S. FDA has given the green light to Roche Group for its Cobas HIV-1/HIV-2 Qualitative test for use on Cobas 6800 and 8800 systems. The test is the first FDA-approved, fully automated polymerase chain reaction (PCR) test that detects and differentiates between human deficiency virus type 1 (HIV-1) and HIV-2, as well including claims for pregnant women and children.
TORONTO – Its Canadian medical device establishment licence now firmly in hand, Toronto-based Internet of Things Inc. (ITT) is set to launch a fever-detection system for identifying possible COVID-19 carriers at the entrances of airports, long term care facilities, schools and other places where people congregate. The Thermalpass is an AI-enabled, deep learning screening system that got its start as a road-related weather sensing system, today detecting elevated body temperature.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: The American Medical Association, Obelisk Ventures, Philips, Quest Diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ctl Amedica, Medtronic, Roche, T2 Biosystems, Transmed7.
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