- NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) has submitted a special 510(k) to the FDA for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 days use.
- According to FDA guidance, a special 510(k) is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k).
- NeuroOne Medical is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation, and ablation solutions.
- In May, the FDA stated that they upheld their decision that the device is not substantially equivalent for extended use based on their analysis of the methodology used for exhaustive extraction testing.
- Today, the agency informed the company that it could submit a new 510(k) with new evidence, specifically regarding the subacute toxicity biocompatibility endpoint.
- Last week, NeuroOne announced a $3.5 million accelerated milestone payment from Zimmer Biomet Holdings Inc (NYSE: ZBH). The amendment will also give Zimmer 350,000 warrants with an exercise price of $3.00 per share.
- Price Action: NMTC shares are down 5.80% at $1.79 during the market session on the last check Tuesday.
Morgan Stanley Upgrades Humana to Overweight, Raises Price Target to $549
Morgan Stanley analyst Ricky Goldwasser upgrades Humana (NYSE:HUM) from Equal-Weight to Overweight and raises the price target from $494 to $549.
