Arineta, a leader in advancing cardiovascular imaging solutions, recently announced that its SpotLight™ Duo cardiac CT scanner has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for low-dose lung cancer screening (LDCT). This regulatory milestone enables healthcare providers to use a single, ultra-fast CT platform for both comprehensive cardiac imaging and essential lung cancer screening, offering more complete and efficient care for high-risk patients. Lung cancer remains the leading cause of cancer deaths in the U.S., with a new patient diagnosed nearly every two minutes. However, advances in screening and treatment have improved outcomes, increasing the national five-year survival rate by 26% to 28.4% over the past five years. Arineta’s new FDA clearance for LDCT on its SpotLight Duo system is set to further these efforts by expanding access to critical, lifesaving imaging necessary for this high-risk population. Doug Ryan, CEO of Arineta, stated that this clearance marks a significant milestone in expanding their role in early detection and preventative care. He emphasized their dedication to growing cardio-thoracic CT as the frontline non-invasive test for diagnosing, therapy planning, and monitoring cardiovascular and thoracic disease. The addition of FDA clearance for Low Dose Lung Cancer CT strengthens their ability to support improved outcomes for patients at high risk of disease.

The SpotLight Duo is an advanced cardiac CT scanner recognized for capturing the entire heart in a single beat, with technical features such as 140 mm coverage and a rapid rotation speed of 0.24 seconds per rotation. It also employs advanced deep-learning image reconstruction (DLIR) technology, which enhances image quality by reconstructing cross-sectional images with greater clarity, resulting in more comprehensive and accurate diagnoses. With the new LDCT clearance, the SpotLight Duo’s utility significantly expands, allowing providers to leverage its speed and precision for both detailed cardiac assessments and effective low-dose lung cancer screening. This dual functionality streamlines patient care pathways and can reduce the need for multiple scanning sessions on different machines.

As awareness grows around preventative imaging and population health strategies, the expanded clearance increases the clinical versatility of Arineta’s SpotLight Duo across a range of healthcare environments. Health systems, physician offices, mobile scanning units, and dedicated imaging centers nationwide can now utilize this single platform for a broader spectrum of diagnostic needs. The inclusion of the LDCT clinical application supports earlier detection of lung cancer, facilitating more proactive and timely care for patients.