Neuroone Medical Technologies Corp
Submit a second 510(k) application for sEEG electrode technology
Delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 7 Jan 2021
- Due
- 30 Jun 2021
- Delivered
- May 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“It plans to submit a second 510(k) application for its sEEG electrode technology in the first half of 2021”
What we found
Evidence strength A What the grades mean
The company submitted its second 510(k) application in May 2021, which falls within the first half of 2021 deadline.
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A Neuroone Medical Technologies Corp 10-Q filed 2021-08-13
“The Company received 510(k) clearance from the FDA to market the initial cEEG product and submitted an application for 510(k) clearance for a second product in May 2021.” ✓ confirmed on the page
Market reaction: the shares moved +9.3% against the S&P 500 over the three sessions around the disclosure (12 Aug 2021 to 17 Aug 2021). What this measures
Checked 24 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory filing
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- sEEG electrode technology 510(k) application
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2021-NMTC-021291 · Corrections policy