Quidel Subsidiary Lands First De Novo Clearance For COVID-19 Serology Tests
VITROS COVID-19 tests from Ortho-Clinical Diagnostics have been cleared by the US FDA, establishing regulatory pathway for future similar tests.
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FDA Finalizes Guidance Documents Aimed At Easing Post-Pandemic Regulatory Transitions
The documents describe the US agency’s preferred approach toward products cleared under EUAs or other alternate approaches during the COVID-19 public health emergency.
News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More
News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.
MDSAP Audit Allows Emerging Firm To Expand Internationally
Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight.