LInks for FDA AI Radiology & New Caption Health AI / US / Cardio device

Business news

https://medcitynews.com/2020/02/fda-oks-first-of-a-kind-ai-that-guides-cardiac-imaging/

https://www.healthcaredive.com/news/fda-oks-1st-ai-tool-to-help-non-specialists-take-cardiac-ultrasounds/572010/



Company

https://captionhealth.com/


FDA press release
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user

Webpage for FDA Feb 25 26 conference

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-evolving-role-artificial-intelligence-radiological-imaging-02252020-02262020


Somewhere I saw name of FDA category eg "AI devices for imaging" 21 CFR 888.xyz
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN190040

Discussion paper
https://www.fda.gov/files/medical%20devices/published/US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper.pdf