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Medical Devices / Submissions and Approvals

Scopis Wins FDA Clearance and Health Canada MDL Clearance for Its Surgical Navigation System

March 1, 2017
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Massachusetts–based Scopis has received FDA marketing clearance and a Health Canada Medical Device License (MDL) for its surgical navigation products for ear, nose and throat surgery.

The technology is based on a small and portable unit that supports optical, electromagnetic and simultaneous hybrid tracking.

The modular device can be adapted for various uses. — Cynthia Jessup

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