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.”
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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.
About Arineta
Arineta, based in Israel, specializes in developing innovative cardiovascular imaging solutions. The company is committed to advancing cardiac CT as the front-line non-invasive method for diagnosing, planning therapy, and monitoring cardiovascular disease, the leading cause of death and healthcare costs worldwide. Arineta’s flagship product, the SpotLight™ Duo, based on the company’s proprietary Stereo CT technology, is the world’s first dedicated single-heartbeat, whole-heart cardiovascular and thoracic CT scanner. Building on its history of medical imaging innovation that began in Israel in the 1970s, Arineta’s team includes the inventors of multi-slice spiral CT technology, still the cornerstone of CT imaging, and several other key technologies.
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