Circle Cardiovascular Imaging vs VUNO

VUNO's DeepBrain (K231398) quantifies brain structures and lesions from MR, and a 2022 PLoS One study reported 96.4% sensitivity and 89.9% specificity for moderate to severe white matter hyperintensity volume. Circle's K212261 is LVO triage on CTA, and StrokeSENS ASPECTS (K250221) adds scoring. For a stroke service that wants triage at the scanner, VUNO falls short, because its two openFDA records are DeepBrain and a chest X-ray triage tool for pleural effusion and pneumothorax in adults (K241439).

VUNO's other buyers are chest X-ray services, retinal screening programs, bone age readers and ward teams using its vital-signs cardiac arrest tool. Circle's other buyer is a cardiac CT or MR reading team.

VUNO's home page and Circle's regulatory page state no HIPAA or SOC 2 status. VUNO lists ISO/IEC 27001:2022 and 27701:2019 certificates valid to November 2028. Circle's regulatory page lists ISO 13485:2016 and MDSAP under quality, so VUNO is the one with an information-security certificate to put in front of a hospital security review.