Cleerly vs Philips Imaging AI

Philips has 49 entries on the FDA's AI-enabled device list as of June 2026 under its own name, 25 of them ultrasound systems with AI features, plus 10 from DiA and 2 from TomTec. It sells the portfolio with scanners and ultrasound systems on enterprise and OEM contracts. For SmartSpeed Precise, the dual-AI MR reconstruction, Philips reports FDA clearance across 1.5T and 3.0T dStream systems in a July 2025 release but gives no K-number, and the release's footnote says "not yet CE marked and not available for sale" while the body says available. Speed and image-quality claims are Philips' own.

Cleerly covers one task, coronary CTA plaque and stenosis analysis, with six 510(k) clearances and coverage from Aetna, UnitedHealthcare and Cigna according to its press materials.

A hospital replacing its MR and CT fleet gets AI inside the equipment contract with Philips. A coronary CTA program that wants plaque volume billed under CPT 75577 is better served by Cleerly, which ties that analysis to the code, six clearances and named payers, while none of the 14 Philips-family K-numbers in the sources is named for coronary plaque. For that program Philips trails.