What You Should Know:
– Arineta, a leader in advancing cardiovascular imaging solutions, 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).
– The regulatory milestone allows healthcare providers to utilize a single, ultra-fast CT platform for both comprehensive cardiac imaging and vital lung cancer screening, offering more complete and efficient care for high-risk patients.
Expanding Access to Critical Lung Cancer Detection
Lung cancer remains the leading cause of cancer deaths in the U.S., with a new patient diagnosed nearly every two minutes. However, advancements in screening and treatment have led to improved outcomes, with the national five-year survival rate increasing by 26% to 28.4% over the past five years. Arineta’s new FDA clearance for LDCT on its SpotLight Duo system is poised to further enhance these efforts by expanding access to the critical, lifesaving imaging necessary for this high-risk population.
“This clearance marks a significant milestone in expanding our role in early detection and preventative care,” said Doug Ryan, CEO of Arineta. “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.”
SpotLight Duo: A Single Platform for Dual Cardio-Thoracic Insights
The Arineta SpotLight Duo is an advanced cardiac CT scanner known for its ability to capture the entire heart in a single beat. It boasts impressive technical specifications, including 140 mm coverage and a rapid rotation speed of 0.24 seconds per rotation. The system also incorporates 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 this new LDCT clearance, the SpotLight Duo’s utility extends significantly. Providers can now leverage its speed and precision for both detailed cardiac assessments and effective low-dose lung cancer screening, streamlining patient pathways and potentially reducing the need for multiple scanning sessions on different machines.
Enhancing Preventative Care Across Healthcare Settings
As awareness grows around the importance of preventative imaging and population health strategies, this expanded clearance increases the clinical versatility of Arineta’s SpotLight Duo across various healthcare environments. Health systems, physician offices, mobile scanning units, and dedicated imaging centers nationwide can now utilize this single platform for a broader range of diagnostic needs. The addition of the LDCT clinical application supports earlier detection of lung cancer, facilitating more proactive and timely care for patients.
