NeuroOne seeks FDA clearance for brain monitoring system; shares up

Neuroone Medical Technologies

12/06/2023 14:15

** Shares of NeuroOne Medical Technologies Corp  NMTC.O  up
9.8% at $1.40 before the bell 
    ** Medical device maker reports 510(k) application
submission to U.S. FDA for clearance of its ablation system,
OneRF 
    ** Co says OneRF technology utilizes existing diagnostic
electrodes surgically implanted into the brain tissue for
lesioning; the device monitors and adjusts temperature settings
during surgery and improves safety of the procedure
    ** Lesioning means small areas of damage (lesions) in the
brain
    ** Co anticipates receiving initial feedback from FDA no
later than Aug. 7, 2023 
    ** Under 510(k) clearance process, medical device
manufacturers need to notify FDA at least 90 days in advance of
their intent to market a device 
    ** As of last close, stock was up 2.5% YTD

 (Reporting by Pratik Jain in Bengaluru)
 ((Pratik.Jain@thomsonreuters.com;))