Digital Diagnostics

What does the vendor say LumineticsCore does?

In the vendor's description, an operator takes two images per eye and submits them, and the result returns within 30 seconds. The vendor states the indication as detecting more than mild diabetic retinopathy, abbreviated mtmDR, and says it was the first company to receive FDA clearance for an AI diagnostic platform that makes a diagnosis without physician input. Its outcome claims include 91% of unnecessary specialty visits avoided in its trial for FDA authorization, eye exam adherence rising from 12% to 30% at Zufall Health, and diabetic retinopathy diagnosed in more than one in four patients tested at Cahaba Medical Care within 90 days. Other customers it names are Tarzana Treatment Centers, Johns Creek Primary Care, OSF HealthCare, Urban Health Plan and AbsoluteCare.

What does the De Novo decision cover?

DEN180001 is IDx-DR, requested by IDx, LLC of Iowa City under product code PIB, "diabetic retinopathy detection device," 21 CFR 886.1100. FDA received it on January 12, 2018 and granted it as a Class II device on April 11, 2018. The FDA-cleared follow-ups are K203629 (June 10, 2021) and K213037 (IDx-DR v2.3, June 17, 2022), both under PIB. FDA's records still use the IDx-DR name and none carries the name LumineticsCore.

The vendor lists CPT 92229 as the reimbursement code. By its account the code was created in 2019, CMS proposed a rule on it in August 2020, and in early 2023 CMS changed the wording from "automated" to "autonomous diagnosis."

What do the published studies report?

A systematic review and meta-analysis of IDx-DR accuracy reports a pooled AUC of 0.95 (PMID 39986640). A comparison of Mona DR and IDx-DR against human grading reports a kappa of 0.43, described as moderate, for IDx-DR and 0.68 for Mona DR. A real-world comparison with ophthalmologist fundoscopy grading reports an exact match of 54.2% and undergrading of 4.8%. The vendor's product page gives no sensitivity or specificity.

The verdict

LumineticsCore suits a primary care clinic that screens adults with diabetes on the Topcon NW400 and wants an autonomous result under CPT 92229, the code the vendor lists as reimbursable. The vendor sells only to healthcare providers.