IDx
The company will use the funds to expand its platform and accelerate global commercialization.
Formerly known as IDx, the company received FDA De Novo clearance in 2018 for its IDx-DR system used to detect diabetic retinopathy.
Digital Diagnostics, formerly IDx, is looking to expand into the skin health space with this new purchase.
As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals.
After landing a De Novo for its AI diagnostic that can detect diabetic retinopathy, the company raised new money in order to expand diagnostic services.
Pivotal trial data that led to April’s de novo clearance of the first AI-based diagnostic system to not require clinician interpretation is now available to the public.
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.
The FDA has granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR.