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The system has an artificial intelligence algorithm that evaluates the images coming from the camera and determines whether or not there’s diabetic retinopathy in them,” explained IDx Founder and President Michael Abràmoff. “So it makes a clinical decision, without someone like me being involved — it’s fully autonomous.”

Artificial intelligence is a healthcare and technology buzzword right now, but IDx Founder and President Michael Abràmoff is not a Johnny-come-lately to this phenomenon. His journey and that of the company’s lead product began over two decades ago in the Netherlands.

The product, LumineticsCore™ (formerly known as IDx-DR), is an AI-based diagnostic system meant to be used as a standalone screening tool for diabetic retinopathy. In February, the company announced that it submitted an application with the FDA, which the agency accepted with a “breakthrough device” designation. In other words, based on its ability to address an unmet medical need, FDA will provide a faster review.

It’s the same unmet need that Abràmoff set out to solve in 1997.