FDA clears upgraded AI for detection, scoring of coronary calcium
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Key takeaways:
- The FDA cleared an upgraded AI algorithm for the detection of coronary calcium.
- The upgrade included several new features, including a zero CAC score category and additional configuration.
Nanox announced its subsidiary, Nanox.AI, received FDA 510(k) clearance for its AI-powered coronary artery disease detection solution.
The upgraded version of the company’s cardiac solution (HealthCCSng V2.0) is seamlessly integrated within existing electronic health record and picture archiving and communication systems and utilizes imaging data from routine non-gated, non-contrast CT scans to automatically measure coronary artery calcium.
The upgraded algorithm also now includes a zero CAC score category to better differentiate zero and low CAC levels; numerical CAC scoring alongside CAC category to improve cardiac risk assessment; and CAC category configuration, enabling users to adjust the lower and upper bounds for the low, medium and high categories of CAC scores, according to a company press release.
“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,” Erez Meltzer, CEO of Nanox, said in the release. “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 health care. We will continue exploring opportunities to seamlessly integrate our AI solutions with health care systems and clinician workflows, and ultimately enhance patient care and outcomes.”
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