Arineta’s SpotLight Duo Cardiac CT Scanner Cleared for Low-Dose Lung Cancer Screening

Arineta’s SpotLight Duo cardiac CT scanner has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for low-dose lung cancer screening (LDCT). The decision allows providers to use a single ultra-fast computed tomography (CT) platform for both cardiac and lung imaging and diagnostics.

The leading cause of U.S. cancer deaths, new lung cancer cases are diagnosed nearly every two minutes. But more lung cancer patients are surviving these days—over the past five years, the survival rate has increased by 26% nationally to 28.4%. Arineta’s FDA clearance expands access to the imaging needed for this high-risk population. 

“This clearance marks a significant milestone in expanding our role in early detection and preventative care,” Arineta CEO Doug Ryan said. “We are dedicated to growing cardio-thoracic CT as the front-line non-invasive test for diagnosing, therapy planning, and monitoring of cardiovascular and thoracic disease. The addition of FDA clearance for Low Dose Lung Cancer CT strengthens our ability to support improved outcomes for patients at high risk of disease.”

As awareness grows around preventative imaging and population health strategies, this clearance expands the clinical utility of Arineta’s SpotLight Duo across health systems, provider offices, mobile scanning units, and imaging centers nationwide, according to the company. With the addition of this clinical application for LDCT, the system supports earlier detection and more proactive care for patients.

The SpotLight Duo cardiac CT scanner captures the entire heart in a single beat, featuring 140 mm coverage at a rotation speed of 0.24 sec per rotation. Its advanced deep-learning imaging reconstruction (DLIR) technology enhances image quality by reconstructing cross-sectional images, resulting in more comprehensive and accurate diagnoses.

Arineta develops cardiovascular imaging solutions. The Israeli company is advancing cardiac CT as the front-line non-invasive method for diagnosing, planning therapy, and monitoring cardiovascular disease—the leading cause of death and healthcare costs worldwide. Arineta’s flagship product, the SpotLight Duo, is based on the company’s proprietary Stereo CT technology and is touted as the world’s first dedicated single-heartbeat, whole-heart cardiovascular and thoracic CT scanner. Building on its history of medical imaging innovation that began in Israel in the 1970s, Arineta’s team includes the inventors of multi-slice spiral CT technology, still the cornerstone of CT imaging, and several other key technologies.