MedTech Dive January 19, 2022
Nick Paul Taylor

Dive Brief:

  • The digital therapeutics sector must overcome regulatory, economic and technical challenges to fulfill its potential in the U.S., according to University of California-San Francisco computational health science researchers.
  • Writing in the peer-reviewed PLOS Digital Health journal, Atul Butte and his coauthors identified digital therapeutics’ support for rapid updates, the limitations of current reimbursement policies and cybersecurity risks among the open challenges faced by the industry. The researchers also concluded there is a “pressing need for new regulatory frameworks in this field,” while noting that “these new digital health tools fall under the FDA’s software-as-a-medical-device (SaMD) category and are subject to regulatory approval, much like conventional medical devices or therapeutic drugs.”
  • The publication of the PLOS paper...

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Topics: Digital Health, FDA, Govt Agencies, Medical Devices, Regulations, Survey / Study, Technology, Trends
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