The CVR Carotid Stenotic Scan (CSS)
The Carotid Stenotic Scan (CSS) is a diagnostic tool designed to detect and measure carotid narrowing for the purpose of identifying patients at risk for Ischemic Stroke. The CSS provides a synergistic tool which complements other stroke screening technology such as Duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), and computed tomography angiography (CTA). CVR’s groundbreaking device is non-emissive, non-invasive, does not require a certified technician, can be conducted in a few minutes, and has a per scan price point that is significantly advantageous as an initial screening tool when compared to the resource requirement associated with other technologies.
At what stage of development is the Carotid Stenotic Scan (CSS)?
CVR has withdrawn its January 2019 De Novo submission for the CSS from the FDA and is expecting to resubmit at a later date.