Source: https://sharpbrains.com/blog/2017/05/30/the-fda-creates-new-digital-health-unit-to-reimagine-regulatory-paths-in-the-age-of-scalable-ai-enhanced-innovation/
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Medicine Is Going Digital. The FDA Is Racing to Catch Up (Wired):
“WHEN BAKUL PATEL started as a policy advisor in the US Food and Drug Administration in 2008, he could pretty much pinpoint when a product was going to land in front of the reviewers in his division. Back when medical devices were heavy on the hardware—your pacemakers and your IUDs—it would take manufacturers years to get them ready for regulatory approval. FDA reviewers could keep up pretty well…Today, machine learning powers more and more medical device software. And because it is always learning and improving, it is constantly changing products on the fly. For most regu…
Source: https://sharpbrains.com/blog/2017/05/30/the-fda-creates-new-digital-health-unit-to-reimagine-regulatory-paths-in-the-age-of-scalable-ai-enhanced-innovation/
—
Medicine Is Going Digital. The FDA Is Racing to Catch Up (Wired):
“WHEN BAKUL PATEL started as a policy advisor in the US Food and Drug Administration in 2008, he could pretty much pinpoint when a product was going to land in front of the reviewers in his division. Back when medical devices were heavy on the hardware—your pacemakers and your IUDs—it would take manufacturers years to get them ready for regulatory approval. FDA reviewers could keep up pretty well…Today, machine learning powers more and more medical device software. And because it is always learning and improving, it is constantly changing products on the fly. For most regu…
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