First At-Home COVID-19 Serology Test From Symbiotica Granted EUA By FDA
The COVID-19 Self-Collected Antibody Test System made by developer Symbiotica Inc. is the first at-home antibody test granted emergency use authorization by the US agency.
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A 5 May report from the US FDA says that even under the best COVID-19 conditions the agency’s inspections of makers of medical and tobacco products will likely be cut in half this year. The FDA also announced it will launch an agency-wide Inspectional Affairs Council to “plan and coordinate inspectional activities.”
US Regulatory Roundup, April 2021: Medical Software, FDA Remote Reg Assessments, Medtronic Recalls, And More
An FDA rule that says the agency will no longer regulate eight different types of medical software, an explainer of the FDA’s Remote Regulatory Assessments, high-risk class I recalls for medtech giant Medtronic, and more topped our list of most-read Medtech Insight articles in April.
Pelvalon CEO Miles Rosen talks the company’s journey from US FDA de novo authorization to Medicare HCPCS payment code for its Eclipse System, a nonsurgical device used for bowel control in women.