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Cognoa preps FDA filing for digital autism diagnostic

pharmaphorum

The FDA has awarded a breakthrough device designation to the app, which means it should have a swift review with a higher level of input from the US regulator. In the US, it is estimated that one in five children are living with a diagnosable behavioural health disorder, however, only 21% of children who are diagnosed receive treatment.

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What we’re expecting in 2021, and beyond…

pharmaphorum

There is an opportunity to address this at scale with digital tools and techniques, and expand support into just about any therapeutic area through the holistic integration of mental and behavioural health solutions that improve patient care. Integration of telehealth strategy into commercial models.