www.fdanews.com/articles/211897-fda-approves-smart-device-for-accurate-placement-of-epidural-injections
FDA Approves Smart Device for Accurate Placement of Epidural Injections
May 10, 2023
Omeq Medical’s EpiFinder — which assists physicians to accurately position an epidural needle for spinal anesthesia — has received regulatory clearance from the FDA.
The current technique — loss of resistance in the epidural space — has been used for epidurals since the 1920s and fails in up to 30 percent of patients, the company said.
EpiFinder is a single-use epidural placement device that integrates with the standard loss of resistance technique and monitors tissue resistance at the needle tip to accurately detect needle penetration into the epidural space.
A clinical study conducted by Omeq resulted in successful epidural blocks in all 31 patients in the study.
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