Company resubmits 510(k) regarding cortical electrode technology directly to the FDA for review
MINNETONKA, MN / ACCESSWIRE / October 1, 2019 / NeuroOne Medical Technologies Corporation (OTCQB:NMTC), a medical device company focused on the development and commercialization of thin-film electrode technology for recording brain activity, stimulation and ablation solutions for patients suffering from Epilepsy, Parkinson's Disease, and back pain, today announced that it has re-submitted its 510(k) submission to the United States Food and Drug Administration (FDA) for its cortical electrode technology.
On August 14, 2019, the Company announced that it had withdrawn its initial 510(k) submission for its cortical electrode technology after the FDA requested additional sterilization data related to the cable assembly that could not be provided within the time period specified by the FDA. The Company also reported that it planned to submit the sterilization information in a subsequent 510(k) submission directly to the FDA once it had successfully obtained the additional data. On September 28, 2019, the Company sent the 510(k) submission to the FDA and receipt was confirmed on September 30, 2019.
"I am very pleased and grateful at how quickly the team was able to respond to the FDA's request given that just last month we informed the market that we needed to perform additional sterilization testing," stated Dave Rosa, NeuroOne's President and CEO. "We look forward to an interactive process with FDA to conclude this process in as expeditious a manner as possible."
NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from Epilepsy, Parkinson's Disease, Essential Tremors and other related neurological disorders that may improve patient outcomes and reduce procedural costs.
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SOURCE: NeuroOne Medical Technologies Corporation