FDA Designates Breakthrough Device Status for MYnd Analytics’ PEER 4.0
Mynd.ai, Inc. American Depositary Shares (MYND)
US:NASDAQ Investor Relations:
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Source: GlobeNewswire
MISSION VIEJO, Calif., Sept. 17, 2018 (GLOBE NEWSWIRE) -- MYnd Analytics, Inc. (NASDAQ: MYND), a market leader in improving the delivery of mental health through the combination of telemedicine and data analytics with augmented intelligence, today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s next generation product PEER 4.0. PEER (the Psychiatric EEG Evaluation Registry) is the company's proprietary clinical phenotype database comprising over 40,000 medication outcomes for over 11,000 unique patients, which is used to predict how a patient will respond to a specific medication. The Company’s original product, now in its third generation, has been continuously registered as a class 1 MDDS since October 2011. Under the Breakthrough Devices program, a provision of the 21st Century Cures Act, the FDA works with medical device developers to expedite regulatory review for diagnostic and therapeutic technologies th
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