Autonomous AI company Digital Diagnostics acquires 3Derm Systems

August 25, 2020

Portable AI systems to diagnose diabetic retinopathy without input from a doctor

Digital Diagnostics, an Artificial Intelligence (AI) company, has acquired 3Derm Systems, a medical technology company offering portable AI systems to diagnose diabetic retinopathy without input from a doctor. The company’s medical device is the first such device with approval to do so. Now, Digital Diagnostics hopes to develop 3Derm's AI system, which detects skin cancer, and plans continued expansion into medical specialties beyond its initial focus on eye care.

The acquisition makes Digital Diagnostics the sole holder of autonomous AI healthcare systems that are De Novo authorized by the U.S. Food & Drug Administration (FDA).

Interest in AI has increased as a result of the COVID-19 pandemic because of its ability to improve healthcare quality, lower costs and reduce disease progression remotely.1 The technology utilizes a computer, not a clinician, to make medical decisions.

Digital Diagnostics’ recent milestones include:

• February 2018: IDx-DR receives Breakthrough Device designation from FDA.

• April 2018: First time FDA issues De Novo authorization for an autonomous AI, IDx-DR, in any field of medicine.

• June 2018: Centers for Medicare & Medicaid Services (CMS) introduces temporary bridge coding, CPT code 92250-TC, for autonomous AI.

• May 2019: CPT Editorial Panel creates the first CPT category 1 code for autonomous AI, 9225X.

• December 2019: American Diabetes Association updates its Standard of Diabetes Care to include autonomous AI for the diabetic eye exam.

• January 2020: 3DermSpot receives Breakthrough Device designation from FDA.

• July 2020: National Committee for Quality Assurance (NCQA) updates Healthcare Effectiveness Data and Information Set (HEDIS) to support the use of autonomous AI for closing the diabetic eye exam care gap.

• August 2020: CMS announces Medicare will pay for autonomous AI.

Related: Alcon kicks off global contact lens awareness campaign


1. Allam Z. The Rise of Machine Intelligence in the COVID-19 Pandemic and Its Impact on Health Policy. Surveying the Covid-19 Pandemic and its Implications. 2020;89-96. doi:10.1016/B978-0-12-824313-8.00006-1