FDA is looking for new companies to test out its pre-cert pilot program
The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.
Insights from the FDA’s digital health lead Bakul Patel at MedCity INVEST
At the MedCity INVEST Conference in Chicago, the FDA's Bakul Patel spoke about the recent developments in the agency's thinking about regulating the emerging Software as a Medical Device space.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Research shows most consumer behavioral health apps have no scientific backing
Based on the literature review conducted by the researchers, only 14 percent of top ranked behavioral health apps described design or development that was based on real-world evidence.
Creating a common language in digital therapeutics
At a workshop convening digital therapeutics companies at the DTX West meeting in San Mateo, California, stakeholders debated what was necessary to build successful business models in the industry while navigating a nascent regulatory pathway.
Challenges and opportunities in FDA’s new digital health regulations
A range of companies at the Digital Health showcase in San Francisco discussed how they view the changing regulatory environment within the category of software as a medical device.
FDA commissioner further details digital health pre-cert program
FDA Commissioner Scott Gottlieb further clarified the pilot program meant to expedite review of digital health technologies and incorporate real world evidence into the regulatory process.
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A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.