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Division of Thermo Fisher Scientific Inc.

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OUS Approvals Analysis: Medtronic Records Another Stack Of Overseas Approvals

With 28 approvals, including 22 CE Marks, February 2017 was the biggest month for non-US medical device approvals on Medtech Insight’s Approvals Tracker since June last year, which had 31 approvals including 27 CE Marks.

Approvals Innovation

Quest Wins First Commercial Zika Test FDA Emergency-Use Approval

FDA approved the first emergency-use authorization for a commercially developed, molecular-based Zika virus diagnostics, developed by Quest's Focus Diagnostics subsidiary.

Medical Device Regulation

CDC’s Zika RT-PCR Test Wins Emergency Approval For Use In CLIA Labs

FDA has approved an emergency-use authorization for a molecular-based Zika virus diagnostic developed by the Centers for Disease Control and Prevention, but the test is limited to use in CDC labs and Clinical Laboratory Improvement Amendments (CLIA) labs, and comes with a long list of conditions for use.

Medical Device North America

ANGLE Targets A Rich CTC Niche In Liquid Biopsy

A multibillion-dollar market is on the way for liquid biopsy, which allows the measurement of markers present in biological fluids, a repeatable method of disease diagnosis that could replace some invasive biopsies and allow clinicians access to tissues that have been inaccessible with current methods. Within this dynamic field, ANGLE PLC is coming closer to clinical application market readiness with its circulating tumor cell harvesting technology, as CEO Andrew Newland explains.

Medical Device Innovation
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