CONTEXT: Interesting article on Google’s continuing move into health tech with their dermatology AI app. The “device” fairs better than dermatologists at recognising skin conditions, apparently, although there are no clinical studies to support the claim. In fact the FDA has not approved the device, although in the EU, the gizmo has gained medical device Class I approval and so can be sold in member states. The article notes that in the EU “you basically fill out a form and self certify” to gain approvals – a note of caution. The EU has just undergone a seismic shift in medical device regulations, so be careful if you are planning on trying to repeat Google’s path to market.
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1. “Google says its skin app has been approved “CE marked as a Class I medical device in the EU,” meaning it can be sold in the bloc and other countries recognizing that standard.”
2. “Google’s new app isn’t clinically validated yet either, but the company’s AI prowess and recent buildup of its health care division make its AI dermatology app notable.”
3. “A Google spokesperson said the company would like to offer the service in the US but didn’t have a timeline on when it might cross the Atlantic; they declined to comment on whether Google has talked with the US Food and Drug Administration about the app but acknowledged the agency’s approval process can be longer.”
4. “Google’s conference last month took place a week before tighter EU rules took effect that Harvey says require many health apps, likely including Google’s, to show that an app is effective, among other things.”
5. “Last month’s demo was brief, and the app’s design is not final, but US experts on AI health software say that Google could face a more involved process from the FDA if it brings its skin app home.”
Source URL: https://www.wired.com/story/google-launches-medical-app-outside-us