FDA Clears Arineta’s Deep Learning Image Reconstruction Tech

Arineta Cardio Imaging has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its deep learning image reconstruction (DLIR) technology for use in the SpotLight family of cardiovascular CT (CCT) scanners. This next-generation image reconstruction technology, powered by artificial intelligence, allows Arineta to provide enhanced image quality and image noise reduction to its customers.
 
DLIR utilizes an advanced deep learning convolutional neural network (CNN) that was trained on more than 3 billion image data points. In comparison to prior technology, DLIR decreases pixel-wise noise magnitude without reducing high-contrast spatial resolution.

“Today, fewer than 5% of U.S. patients that need cardiac CT are getting appropriately scanned due to lack of access at point-of-care,” Arineta CEO Scott Schubert stated. “This FDA clearance continues Arineta’s vision and leadership to make cardiac CT the front-line imaging test for patients with chest pain and suspected cardiovascular disease, as recommended by the ACC & AHA 2021 guidelines.”
 
DLIR is available on both of Arineta’s second-generation systems, including the SpotLight dedicated cardiovascular computed tomography (CT) and SpotLight Duo cardio-thoracic CT systems. SpotLight CT systems with DLIR are indicated for diagnosis of disease or abnormality and for planning of therapy procedures.

“We have used Arineta cardiac CT systems for several years, and they provide the highest quality cardiac CT clinical images for our practice,” said Matthew Budoff M.D., professor, Endowed Chair of Preventive Cardiology at Harbor-UCLA. “From our FDA 510(k) reader study, Arineta’s DLIR technology continues that excellence. Arineta’s SpotLight systems make the highest performance cardiac CT available at point-of-care, in an office, mobile, or cath lab setting.”

Arineta Cardio Imaging is an Israeli company that develops and produces cardiovascular imaging solutions. Arineta is dedicated to growing cardiac CT as the front-line non-invasive test for diagnosing, therapy planning and monitoring of cardiovascular disease, the leading cause of death and costs for healthcare worldwide. Arineta’s flagship product, SpotLight Duo, is the world’s first dedicated single-heartbeat, whole-heart cardiovascular and thoracic CT, based on the company’s proprietary Stereo CT technology. Among Arineta’s scientists are the inventors of the multi-slice spiral CT technology, still the cornerstone of CT imaging.