European Regulators Approve Two Cardiovascular CT Scanners Developed by Arineta

Arineta has obtain EU MDR (Medical Device Regulation) approval for its SpotLight and SpotLight Duo cardiac CT (computed tomography) scanners.

The EU MDR sets quality standards for medical devices sold in the European Union, with an emphasis on safety, risk management, and post-market surveillance. It replaces the former Medical Device Directive 93/42/EEC (MDD), introducing a more stringent framework and heightened requirements for European market approval.

“Achieving EU MDR CE Mark approval is a significant milestone, reflecting the professionalism of our cross-functional teams and our commitment to regulatory excellence,” Arineta Interim CEO Einav Ehre said. “This certification validates the safety and performance of our technology while expanding our ability to bring advanced cardiovascular imaging solutions to healthcare providers and patients across Europe. We remain focused on setting new standards in cardiac imaging and driving meaningful impact worldwide.”

Arineta’s flagship systems—SpotLight and SpotLight Duo—are reportedly the world’s first dedicated cardiovascular CT scanners designed for single-beat, whole-heart imaging. SpotLight is a cardiovascular CT scanner that provides comprehensive imaging for diagnosis and therapy planning, with full heart coverage in a single heartbeat and a lower radiation dose than a whole-body CT scan. The Duo system adds high-resolution thoracic clinical capabilities for lung cancer and other pulmonary diseases to its cardiovascular CT technology.

By reducing the footprint and cost typically associated with cardiac CT, Arineta executives claim the company is improving access to advanced diagnostics and enabling broader adoption across healthcare providers.

Based in Israel, Arineta advances cardiovascular imaging solutions through cutting-edge technology. Since its establishment in late 2006 by Dr. Ehud Dafni and Yosi Morik, Arineta has pushed the boundaries of medical imaging. Located in Caesarea Industrial Park, the company benefits from a rich tradition of medical imaging innovation that traces back to the 1970s. Arineta is comprised of highly skilled scientists, engineers, and accomplished business executives with a significant medical device development and commercialization experience.