Arineta Secures EU MDR CE Mark for SpotLight and SpotLight Duo Cardiovascular CT Scanners

Approval validates compliance with Europe’s most stringent medical device standards and supports continued market expansion.

• Arineta’s SpotLight and SpotLight Duo cardiac CT scanners received EU MDR (2017/745) approval, enabling commercialization in Europe.
• The SpotLight systems are dedicated cardiovascular CT scanners capable of single-beat, whole-heart imaging, with the Duo model adding thoracic imaging for pulmonary conditions.
• Approval underscores Arineta’s commitment to regulatory excellence while expanding access to advanced cardiovascular imaging for healthcare providers and patients across Europe.

Caesarea, Israel – March 30, 2026 – Arineta, a leader in advancing cardiovascular imaging solutions, today announced that its SpotLight and SpotLight Duo cardiac CT scanners have now received approval under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR. This approval reflects Arineta’s ongoing commitment to regulatory excellence and high-quality standards, while enabling access to the European market under EU regulations.

The EU MDR sets quality standards for medical devices sold in the EU, 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 market approval in Europe.

“Achieving EU MDR CE Mark approval is a significant milestone, reflecting the professionalism of our cross-functional teams and our unwavering commitment to regulatory excellence,” said Einav Ehre, Interim CEO of Arineta. “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 the world’s first dedicated cardiovascular CT scanners designed for single-beat, whole-heart imaging. SpotLight is a dedicated cardiovascular CT scanner designed to deliver comprehensive imaging for diagnosis and therapy planning, with full heart coverage in a single heartbeat and 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 is improving access to advanced diagnostics and enabling broader adoption across healthcare providers. Through this approach, the company continues to push the standard of care and expand possibilities in cardiovascular imaging worldwide.

For more information about Arineta and its solutions, visit arineta.com.