FDA OK’s Insomnia Treatment Through Software Pre-Cert Program

Pear Therapeutics’ Somryst insomnia treatment tool has become the first FDA-cleared product that was reviewed through the agency’s Software Precertification Pilot Program.

Somryst Hero
• Source: Pear Therapeutics

The US Food and Drug Administration has cleared Pear Therapeutics Inc.'s Somryst chronic insomnia treatment, making it the first product to emerge from the agency’s software precertification pilot program.

The treatment, which Pear calls a prescription digital therapeutic (PDT), operates on a mobile device such as a smartphone or...

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