Under the program, the FDA will provide Cognoa with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions. Read full article here.
Cognoa Receives FDA Breakthrough Designations for Autism Diagnostic and Digital Therapeutic Devices.
PALO ALTO, Calif., Feb. 06, 2019 (GLOBE NEWSWIRE) — Cognoa, a company at the forefront of digital behavioral health for children, today announces it has received Breakthrough Device designations from the U.S. Food and Drug Administration (FDA) for its lead products, the first digital diagnostic and digital therapeutic devices for autism. These products are the foundation of Cognoa’s precision health platform…
Email Print Friendly ShareJanuary 08, 2019 09:03 ET | Source: Cognoa PALO ALTO, Calif., Jan. 08, 2019 (GLOBE NEWSWIRE) — Cognoa, a digital behavioral health company, announced today that Cambia Health Solutions, Inc. (Cambia) is incorporating Cognoa’s evidence-based platform within its subsidiary health plans. Cognoa provides support for employees caring for children older than one. Cognoa offers reliable guidance on day-to-day challenges and personalized resources that enable…
PALO ALTO, Calif., Aug. 27, 2018 (GLOBE NEWSWIRE) — Cognoa, a digital behavioral health company, today announces results from a clinical study of its second-generation AI based algorithms which demonstrates accuracy improvements over its first-generation screening algorithm in supporting the diagnosis of autism spectrum disorder (ASD) in young children. Published in Journal of the American Medical Informatics Association, the data provides…
In May, a pair of studies were published in the journals Autism Research and the Journal of the American Medical Informatics Association (JAMIA) that evaluated Cognoa’s artificial intelligence-based tool for early identification of autism in children. While both investigations suggest that the tool’s performance significantly exceeded those of other standardized screeners. Read full article here.
PALO ALTO, Calif., June 12, 2018 (GLOBE NEWSWIRE) — Cognoa, a digital behavioral health company, today announces its partnership with SAP, a market leader in enterprise application software. More than 19,000 SAP employees in North America will now have access to Cognoa’s app to help their children reach their full potential – socially, emotionally and developmentally. Cognoa empowers employees with clinically validated…
PALO ALTO, Calif., Feb. 21, 2018 (GLOBE NEWSWIRE) — Cognoa, a company offering an AI-based platform for pediatric behavioral health diagnostics and digital therapeutics, announces that the U.S. Food and Drug Administration (FDA) has established that Cognoa’s software is a Class II diagnostic medical device for autism. This milestone will expand Cognoa’s ability to offer its solution to enterprise customers,…
PALO ALTO, CA–(Marketwired – Jun 14, 2017) – Cognoa, a digital health company revolutionizing how children with developmental delays are diagnosed and supported, today announces Sharief Taraman, MD as its vice president of medical and clinical. Dr. Taraman will lead the company’s further clinical validation of Cognoa’s child development software for payers and employers as well as the company’s U.S. Food…