FDA Clears Cardiovascular CT Systems From Arineta

Arineta Cardiac Imaging announced US FDA 510(k) clearance of the SpotLight and SpotLight Duo family of cardiovascular CT (CCT) scanners. Both are dedicated cardiovascular CT systems with the Duo system adding a high-resolution thoracic clinical capability, including for lung cancer, COVID19, and other pulmonary diseases. The two systems add extended coverage for peripheral vascular and runoff studies, a rapidly growing procedure for vascular therapies.

 “Arineta has been the leader in cardiovascular CT technology, and the new SpotLight systems continue Arineta’s history of clinical innovation,” said Scott Schubert, Arineta CEO. “Our vision is to grow cardiac CT as the front-line non-invasive test for diagnosing, therapy planning and monitoring of cardiovascular disease- the number one cause of death and costs for healthcare worldwide.”

“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,” said Chaim Lotan, MD, professor at Hadassah-Hebrew University. “According to the World Health Organization, four of the top six causes of death are cardiovascular and thoracic diseases.”

The SpotLight system is a 25 cm Field of View (FOV) dedicated CCT system, enabled by Arineta’s proprietary Stereo CT technology. SpotLight has best-in-class specifications for temporal resolution (120 msec), one beat whole-heart coverage (14 cm), spatial resolution (0.5 mm detector), and x-ray tube power for superior image quality (139 kW effective). SpotLight Duo is the second generation of Arineta CT technology, with 45cm high resolution scanning for full cardiothoracic clinical applications. Both systems include workflow advances for higher patient throughput.