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https://www.federalregister.gov/documents/2022/11/23/2022-23918/medicare-program-hospital-…

…her similarly disposable devices. We also noted that the applicant cited an FDA news release 104 in support of single use duodenoscopes to reduce risk of infection, but this is not the device in question. Additionally, the previously referenced FDA advisory letter 105 regarding u…

https://www.federalregister.gov/documents/2020/12/29/2020-26819/medicare-program-hospital-…

…isease diabetic retinopathy in adults who have diabetes” ( https://www.fda.gov/​news-events/​press-announcements/​fda-permits-marketing-artificial-intelligence-based-device-detect-certain-diabetes-related-eye ). Approved for marketing by the FDA in April 2018, the artificial inte…