Flat Medical's EpiFaith Smart Syringe Receives FDA Clearance for US Use
1 report, 1 independent
Updated Wed 00:00
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What happened
Flat Medical announced that its EpiFaith Smart Syringe has received FDA 510(k) clearance for use in the United States. The device provides real-time visual pressure feedback to help clinicians identify the epidural space during procedures. Over 30 hospitals and pain management centers have adopted the syringe in routine clinical practice, and several major integrated delivery networks have begun groundwork for system-wide conversion.
From manilatimes.net
Why it matters
The clearance and subsequent adoption indicate growing market acceptance for precision needle access solutions. This milestone suggests a potential shift from early adoption to a new standard in epidural access care across the United States.
From manilatimes.net
Who's involved
- FDARegulatory agency that cleared the device
- Mark RabeVice President of North America at Flat Medical
- Center for Devices and Radiological HealthFormal division of the FDA that issues alerts and holds meetings
- United States of AmericaMarket where the device is cleared for use