Of interest to some holders will be the expedited approval...

Of interest to some holders will be the  expedited approval process and timeline given to IDx and their diabetic retinopathy AI diagnostic tool by the FDA. In April it became the first autonomous diagnostic that is FDA approved for commercialisation.



The FDA clinical study was completed in December 2017. The technology was given expedited review by the FDA as a breakthrough device. Clearance was announced by the company 12 April (roughly 3 months) and the product was immediately available for purchase to clients: "IDx-DR is available for immediate installation". FDA's press release stated: “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”


Results were published yesterday in Nature Digital Medicine:


Dr. Michael Abramoff, the trial's principal investigator and president of IDx, will discuss the recently released clinical trial data behind the FDA clearance in a webcast tomorrow morning 3am AEST. You can register here:
https://www.eyediagnosis.net/

Let's hope that we can match or surpass those diagnostic accuracy markers. If so, we could be commercial in the US before year's end. GLTAH