electroCore Provides Update on 510(k) Submission Seeking Expanded Indication for gammaCore™
electroCore, Inc. (ECOR)
Last electrocore, inc. earnings: 3/23 04:05 pm
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Source: GlobeNewswire
BASKING RIDGE, N.J., Sept. 25, 2019 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR, or the “Company”), a commercial-stage bioelectronic medicine company, today announced that the U.S. Food and Drug Administration (“FDA”) has requested more information and analysis of the clinical data included in the Company’s premarket notification, or “510(k)” submission, seeking an expanded indication for the use of gammaCore™ (non-invasive vagus nerve stimulator). Although the Company has 180 days to respond to FDA’s request, the Company expects to meet with the FDA in the fourth quarter to discuss the information request. gammaCore™ is currently FDA-cleared for the treatment of pain associated with episodic cluster headache and migraine headache, and adjunctive use for the prevention of cluster headache. The data submitted in the 510(k) include the results of the Premium 1 study, a randomized, double-blind, sham-controlled trial of gammaCore™ recently published in the journal Cephalalg
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- 11/13/24 - Miss
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- 11/15/24 - Form D
- 11/13/24 - Form 10-Q
- 11/13/24 - Form 8-K
- ECOR's page on the SEC website