Nano X Imaging has announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, has received 510(k) clearance from the US Food and Drug Administration (FDA) for HealthCCSng V2.0.
HealthCCSng V2.0 is the upgraded version of Nanox.AI’s cardiac solution, HealthCCSng, which is used to identify patients at high risk of coronary artery disease
The system utilises medical imaging data from routine non-gated, non-contrast computed tomography (CT) scans that include the entire heart of adult patients of ages 30–85 to automatically measure coronary artery calcium (CAC).
“We are pleased to receive another regulatory clearance from the FDA for our AI cardiac solution, with new updates that reflect our commitment to providing healthcare professionals with the tools they need,” said Erez Meltzer, Nanox chief executive officer. “The AI cardiac solution helps to bridge the divide between radiology and cardiology, two medical specialties that often use different terms and descriptions to assess imaging data, and catches patients who might otherwise fall through the cracks so that they can be directed to appropriate preventative healthcare.
“We will continue exploring opportunities to seamlessly integrate our AI solutions with healthcare systems and clinician workflows, and ultimately enhance patient care and outcomes.”
