‘Major Milestone:’ FDA Gives CLIA Waiver To Chlamydia, Gonorrhea Test
The 30-minute Binx IO test will now be available to more than 220,000 point-of-care facilities that have a CLIA waiver. Health experts say it will help treat patients faster and stymie the spread of STIs.
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The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.
Digital Health Roundup, March 2021: Record-Breaking Funding; Exec Chats With Medtronic, Edwards LifeSciences
In this new roundup feature focusing on the most notable developments in digital health, we pick the key news to date.