Software Precertification Pilot Program News Today

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital...

Nox Health is set to acquire Somryst, a prescription digital therapeutic for chronic insomnia treatment, from Pear Therapeutics.

There has been a lot of discussion lately of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023...

There has been a lot of discussion lately of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated...

Food and Drug Omnibus Reform Act of 2022 FDORA enacted on December 29, 2022 as part of larger Consolidated Appropriations Act for 2023. Future reforms medical product developers, review last year actions policy updates on digital health from Food and Drug Administration.

Some experts assert the legislation is preemptive and may stifle innovation, while others argue it has the potential to improve patient access to meaningful healthcare.

Somryst is the only FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia Analysis demonstrated potential per-patient cost reductions over 24 months of

FDA launched the Pilot Program to study whether information collected at multiple points during the total life cycle of a software product could be an efficient and successful approach to assess the safety and effectiveness of medical device technologies.

Press release content from Business Wire. The AP news staff was not involved in its creation.

Press release content from Business Wire. The AP news staff was not involved in its creation.