Eyenuk vs Infervision

FDA clearances for Infervision cover CT products and software: InferRead Lung CT.AI (K192880 on July 2, 2020, K240554 on May 16, 2025), InferRead CT Stroke.AI (K211179 on August 12, 2021), InferOperate Suite (K250237, K260973) and InferCare RECIST (K252261). The chest X-ray product, InferRead DR Chest, has no openFDA record under Infervision's three applicant names. A 2025 PLOS Global Public Health evaluation by independent authors tested that chest X-ray product for TB screening in Lusaka, Zambia and reported 90.3% sensitivity and 39.2% specificity at a cut-off of 0.12. The vendor says its Lung CT product runs on premise or in the cloud.

Eyenuk states HIPAA, SOC 2 Type 2, GDPR and ISO 13485:2016 compliance, and its home page claims a Class IIb CE mark under EU MDR for DR, AMD and glaucoma detection. Infervision's Lung CT page shows FDA, NMPA and UKCA badges and names no HIPAA, SOC 2 or ISO certification. Radiology departments reading chest and head CT look to Infervision, and diabetes screening sites look to Eyenuk.