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.
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MedCity News Pivot Podcast: How Emergency Departments Are Using Real-Time Data to Improve Outcomes
How can AI benefit and improve patient outcome in the emergency department? Watch the latest episode to find out.
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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Esperion Sets Its Sights on New Areas While Maintaining Commitment to Cardiovascular Health
In a recent interview, Esperion president and CEO, Sheldon Koenig talks about the reality of statin intolerance and his company’s expansion into new diseases