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One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let software as a medical device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.

Regulation Digital Health

CDRH Will Experiment With Pre-Cert Pilot Participants To Figure Out Right Metrics, Processes

With a regulatory framework and test plan in place, US FDA says it will use the rest of the year to run experiments in its pre-cert pilot program to figure out what metrics it needs to gather and processes it needs to develop to make the new paradigm for digital health products a reality. The agency says it plans to update stakeholders as needed on its progress.

Digital Health Regulation

2019 Will Be Testing Period For US FDA's Novel Pre-Cert Paradigm For Digital Health

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

Regulation Digital Health

Market Intel: Digital Tech At The Heart Of Cardiology Innovation

Digital health technologies from smartphone applications, wearables, digital weight scales and telehealth are rapidly changing the landscape of cardiac care, offering new tools for engaging cardiology patients and enhancing cardiologists' workflows. There is a lot of hype, but also some real promise. Here's a look at what's happening and some expert insights on the benefits and challenges these new innovations represent, as well as market projections. Digital health was a major topic of discussion by cardiologists and entrepreneurs during this year's Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego. This is the second in a series of articles on the future of cardiovascular technology, spotlighting discussion and presentations from TCT.

Digital Health Cardiology
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