The FDA admits a diagnosis without a physician
On 11 April 2018 the FDA permitted the marketing of IDx-DR, software that decides from fundus photographs whether an adult with diabetes has more than mild retinopathy. The FDA called it the first authorised device whose screening decision needs no clinician to interpret the image as well.
Why it matters
For the first time a machine was allowed to decide whether a disease is present in an office with no ophthalmologist. The FDA created a new device type for it: class II retinal diagnostic software.
In the pivotal study 900 participants were enrolled at 10 primary care sites and 819 fully analysed: sensitivity 87.4% and specificity 89.5% against prespecified thresholds of 85.0% and 82.5%; a result was produced in 96.1% of cases. The authorisation is narrow: only with the Topcon NW400 camera, only for adults not previously diagnosed with retinopathy; the software detects no other eye disease, glaucoma included, and a positive result means referral to an eye specialist. The record rests on the FDA's documents; the developers' paper on the same study was not used.