Zebra Medical Vision Gets 510(k) Clearance for Coronary Artery Calcium Software

September 29, 2021

Israel-based Zebra Medical Vision has gained 510(k) clearance from the FDA for its coronary artery calcium software, HealthCCSng, which previously earned a CE mark.

The HealthCCSng software analyzes routine CT scans to quantify coronary artery calcium and categorize the patients into three types, depending on how much calcium is detected.

The software is intended to help clinicians identify problems and recommend preventative treatments before a coronary event occurs.

Zebra Medical Vision is currently merging with another Israel-based company, Nanox, that is focused on developing medical imaging applications.

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