FDA Confirms 510K Path for Brainsway's Deep TMS Device
(firmenpresse) - JERUSALEM, ISRAEL -- (Marketwire) -- 07/28/11 -- Brainsway Ltd. (TASE: BRIN) is pleased to report that the U.S. FDA has confirmed that the regulatory approval process for Brainsway's Deep TMS device for the treatment of major depression disorder (MDD) will be the Pre-Market Notification (510(k)) process. This is the simpler and faster route, which is required in a case where the device is equivalent in usability, safety and efficacy to an approved predicate device.
To the best of the company's knowledge, the duration of such a route is usually between three and 12 months from the day of the requested submission which should include the results of the clinical multi-center study, although there might be cases where the duration is longer.
As part of the regulatory process, Brainsway is continuing to conduct the multi-center study in MDD in 22 sites around the world.
About Brainsway Ltd.
Brainsway Ltd. is dedicated to the development and marketing of Deep TMS (Transcranial Magnetic Stimluation) systems - novel, noninvasive medical devices for treatment of a wide range of neurological and psychopathological disorders. In principle, any brain-related disorder that is associated with pathological activity of specific brain sites may be treated by this method. Potential applications include addiction, schizophrenia, obesity, eating disorders, Parkinson's disease, Alzheimer's disease, autism and post-traumatic stress disorder.
Our initial focus is the treatment of major depression. The unique technology of Brainsway is based on patents filed by the U.S. National Institute of Health (NIH) and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Headquartered in Jerusalem, Israel, the company's ordinary shares and warrants trade on the Tel Aviv Stock Exchange under the symbol 'BRIN'.
Forward-Looking Statements
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
Contacts:
Kilmer Lucas Inc.
Stephen Kilmer
President
(212) 618-6347
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Datum: 28.07.2011 - 18:05 Uhr
Sprache: Deutsch
News-ID 39067
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JERUSALEM, ISRAEL
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Medical Devices
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