Digital Health Roundup: Digital Therapeutics Push Ahead On Standards, Coverage; FDA’s Software Guidance
In this roundup feature focusing on developments in digital health, we highlight the key news and announcements from October.
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The principals recommended by the three countries could be the foundation for how their regulatory bodies intend to regulate future AI/ML products.
The US agency’s device center on 26 October published its A and B lists of guidance documents it will prioritize in fiscal year 2022, including drafting guidances to transition emergency use authorized products to full marketing status, and finalizing a clinical decision support software guidance that’s been four years in the making.
With the acquisition of Lemonaid Health, at-home genome testing company 23andMe hopes to transform the primary care business with genetics insights.