FDA approves new AI-powered imaging software from Nanox subsidiary

Nanox.AI, a subsidiary of Israeli healthcare technology company Nano X Imaging (Nanox), has gained U.S. Food and Drug Administration (FDA) approval for HealthCCSng V2.0, a new version of its advanced artificial intelligence (AI) offering for evaluating heart patients.

HealthCCSng was designed to identify patients who may face an increased risk of developing coronary artery disease by calculating coronary artery calcium (CAC) scores based on non-contrast cardiac CT scans. The newly approved technology can be integrated into a healthcare provider’s picture archiving and communication system (PACS) or electronic medical record (EMR). According to Nanox.AI, HealthCCSng takes advantage of the high utilization of CT in today’s healthcare environment, using imaging results originally captured for a variety of reasons to screen patients and deliver automated CAC scores. Its results are made available to cardiologists and radiologists alike as a part of their everyday workflows.

“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, Nanox CEO, said in a statement. “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.”

HealthCCSng V2.0 includes multiple updates compared to the previous version. It can now differentiate patients with zero CAC levels from those with low CAC scores, for example. It also provides more data with each CAC score to ensure care teams have the information they need to make more accurate risk assessments.  

Nanox.AI was previously known as Zebra Medical Vision before it was acquired by Nanox and renamed in 2021. The deal was for an upfront payment of $110 million and up to an additional $84 million based on various milestones.

Michael Walter
Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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