LUMINEX: Submits Emergency Use Authorization Request to U.S. FDA for COVID-19 Antibody Test
Assay uses multiplexing for highly specific and sensitive detection of IgG antibodies against SARS-CoV-2
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ENVOY MEDICAL: Receives FDA Breakthrough Device Designation for its Fully Implanted Acclaim® Cochlear Implant
Also Celebrates 10-Year Anniversary of Invisible Hearing with Esteem® FDA Approval
FDA: Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
The U.S. Food and Drug Administration took important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.