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Medical Devices / Submissions and Approvals

Saranas Wins Novo Designation for Endovascular Bleed Monitor

March 8, 2019
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The FDA granted Saranas a de novo designation for its Early Bird endovascular bleed monitoring system.

The Early Bird incudes a vascular access sheath equipped with sensors to detect and monitor bleeding from blood vessels that have sustained damage from endovascular procedures like TAVR and hemodynamic support device placement.

The company said that the Early Bird is the only device on the market designed for early bleed detection.

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