ElectroCore Shares Up After Device Gets FDA Breakthrough Device Designation
12 Janeiro 2022 - 11:17AM
Dow Jones News
By Michael Dabaie
ElectroCore Inc. shares were up 8.4% to 58 cents premarket
Wednesday after the company said its gammaCore non-invasive vagus
nerve stimulation received U.S. Food and Drug Administration
breakthrough device designation for the treatment of posttraumatic
stress disorder.
The commercial-stage bioelectronic medicine company said the
designation came after the device showed a reduction of symptoms of
PTSD by 31% when compared to sham.
The goal of the breakthrough devices program is to provide
patients and health care providers with timely access to critical
medical devices by speeding up their development, assessment, and
review, while preserving the statutory standards for premarket
approval, 510(k) clearance, and De Novo marketing
authorization.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
January 12, 2022 09:02 ET (14:02 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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