Tag: FDA Clearance

BacterioScan Receives FDA Clearance for Rapid Infection Detection System

BacterioScan, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a 510(k) Premarket Notification clearance for its 216Dx Urinary Tract Infection (UTI) detection system. The BacterioScan 216Dx system...
Abby Cohen Sparo Labs

Sparo Labs’ Abby Cohen on Getting FDA Clearance for Wing

Earlier this month, WashU-bred biotech company Sparo Labs, headed up by co-founders Abby Cohen and Andrew Brimer, learned their Wing device gained FDA clearance. Wing hooks a sensor to a smartphone to measure...

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