IntuiTap Medical has received approval from the US Food and Drug Administration (FDA) for its handheld imaging tool, VerTouch, designed to enhance the accuracy and consistency of spinal punctures.
This clearance validates the new device’s safety and effectiveness.
VerTouch can assist healthcare providers in performing spinal punctures at the bedside with greater precision.
The traditional method, which involves palpating the patient’s vertebrae and inserting the needle without visual aid, results in a high rate of first-attempt failures, ranging from 40% to 60%. These failures can lead to patient trauma.
IntuiTap Medical co-founder and CEO Jessica Traver said: “Receiving FDA clearance for our novel VerTouch device marks a crucial milestone in our team’s journey to making epidurals, spinals, and lumbar punctures more accurate and efficient.
“We are proud to have developed a device that can improve procedure experience and outcomes for providers and patients alike, while also saving healthcare systems the cost of failed attempts. We cannot wait to begin launching VerTouch in hospitals across the country within the year.”
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The VerTouch features spinal mapping technology to generate a 2D image of the lumbar spinal anatomy. This allows providers to visualise key landmarks and guide needle placement.
IntuiTap said the device is expected to improve patient outcomes, reduce anxiety and treatment refusals, and decrease radiology referrals.
The company is exploring global partnerships to expand the reach of its VerTouch device, which is anticipated to be available to patients within the year.
The device has been tested at medical institutions across the US, including the Texas Medical Center and Northwestern Memorial Hospital.