FDA clears next-generation cardiovascular, thoracic CT scanners

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Key takeaways:

• The FDA granted 510(k) clearance for two next-generation cardiovascular CT scanners.
• The new system adds high resolution thoracic imaging on top of dedicated cardiac CT.

Arineta Cardio Imaging announced the FDA 510(k) clearance and launch of its next generation cardiovascular CT scanners.

The system (SpotLight) is designed for cardiovascular CT, and the next-generation product (SpotLight Duo) adds high-resolution thoracic imaging for the detection of lung cancer, COVID-19 and other pulmonary diseases, according to a company press release.

The system is designed to provide a 25 cm field of view and features 120 msec temporal resolution, one beat whole heart coverage, spatial resolution with a 0.5 mm detector and a 139kW effective X-ray tube, according to the release.

The next-generation CT scanner also features 45 cm high resolution scanning for full cardiothoracic clinical applications, according to the release.

“The recent change in guidelines from the ACC and AHA are now clear that cardiac CT is the Level 1A evidence recommended test for diagnosis of stable and acute chest pain,” Chaim Lotan, MD, head of the Hebrew University of Jerusalem’s Hadassah Medical Center Heart Institute and medical director for Arineta Cardio Imaging, said in the release. “According to the World Health Organization, four of the top six causes of death are cardiovascular and thoracic diseases.”

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