Israel-based Arineta has received approval under the European Union (EU) Medical Device Regulation 2017/745 for its SpotLight and SpotLight Duo cardiovascular CT scanners, enabling commercialization across Europe.
The SpotLight system is designed to deliver single-beat, whole-heart imaging with a radiation dose lower than a whole-body CT scan, according to the company. The Duo model adds thoracic imaging capabilities for lung cancer and other pulmonary conditions to the cardiovascular CT platform, Arineta said.
According to the company, the products support advanced diagnostics and reduce the footprint and cost typically associated with cardiac CT.
