NeuroMetrix Seeks FDA Approval for New Pain Therapy Device
NeuroMetrix has announced it has filed an FDA 510(k) application for its SENSUS pain therapy device, according to a news release.
SENSUS is a non-invasive transcutaneous electrical nerve stimulator intended to be used for the symptomatic relief and management of chronic intractable pain, such as diabetic neuropathy, according to the company.
"The filing of a 510(k) for SENSUS represents a key milestone in this product development program," said Shai N. Gozani, MD, PhD, president and CEO of NeuroMetrix, in the release. "We look forward to feedback from the FDA and working towards a timely clearance. Once commercialized, we believe that SENSUS will complement NC-stat DPNCheck, our sural nerve conduction test for DPN, and move us towards our goal of creating a unique and valuable diabetic neuropathy product portfolio and franchise."
NeuroMetrix is based out of Waltham, Mass.
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