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Flat Medical EpiFaith Epidural Syringe Cleared
05/17/2019
 

FDA has cleared a Flat Medical 510(k) for its EpiFaith syringe to deliver safe epidural locating solution. Compared with traditional practice that relies on a manual sense, EpiFaith provides an “intuitive signal” that alerts anesthesiologists when it has arrived in the epidural space, according to the company. The device is intended to prevent accidental punctures to dura, avoiding the risk of serious headache, paralysis, prolonged admission time, and related healthcare costs, it says.


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