News We’re Watching – US FDA Updates, Digital Therapeutics Legislation, AI Endoscopies, Monkeypox EUA, And New AdvaMed Chair
The US Food and Drug Administration recently issued updates regarding improvements to its online submissions portal, enhancements to its electronic medical device reporting system, pediatric X-ray guidance, expanded indications for a popular breathing device, and mammogram guidelines; and more news we’re watching.
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The US agency announced this week that it’s reviewing multiple reports of a form of carcinoma that arises in the scar tissue around a breast implant.
There are fewer than a handful of prescription video game digital therapeutics with regulatory clearance, but gamification in patient care is proving its worth as a novel way of treating a range of conditions, from vision loss to dyslexia and ADHD. Now, the onus is on lawmakers and insurers to create a clear path towards reimbursement.
The guidance document explains the history of and requirements for electronic submissions of 510(k)s.