Omeq Medical announced today that it has received regulatory clearance from the FDA for EpiFinder, which assists physicians to accurately position an epidural needle while performing the standard Loss of Resistance ("LOR") technique.
EpiFinder is a sensor-based, battery-operated single-use epidural placement device for safe, accurate epidural injections. The simple, easy-to-use device fits between a standard needle and syringe, requires no capital equipment, and is compatible with standard epidural syringes on the market. The device integrates seamlessly with the standard LOR technique and monitors tissue resistance at the needle tip to accurately detect needle penetration into the epidural space, protecting the patient from complications associated with misplacement.
Omeq conducted a first-in-human clinical study to demonstrate the safety and effectiveness of EpiFinder. The study results confirmed that Omeq's solution is safe and reliable to use to accurately place an epidural needle. During the study the participating physicians were able to safely provide successful epidural block in 100% of the thirty-one (31) patients while using the device, commenting positively on the ease of use and the benefits that the device offers.
