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Arineta Cardio Imaging gets FDA nod for cardiac CT reconstruction software

by John R. Fischer, Senior Reporter | November 29, 2023
Artificial Intelligence CT X-Ray
Arineta Cardio Imaging's Spotlight Duo cardiovascular CT scanner (Photo courtesy of Arineta)
Point-of-care cardiovascular CT maker Arineta Cardio Imaging has scored 510(k) clearance for its deep learning image reconstruction (DLIR) technology, which reduces noise on scans produced with the company’s SpotLight family of cardiovascular CT (CCT) systems, to capture quality images of single heartbeats.

Arineta’s DLIR software uses a convolutional neural network trained on over three billion image data points to decrease pixel-wise noise magnitude without reducing high-contrast spatial resolution.

It is available on the company’s second-generation SpotLight dedicated cardiovascular CT and SpotLight Duo cardio-thoracic CT, which is the world's first dedicated single-heartbeat, whole-heart cardiovascular and thoracic CT, and based on Arineta’s proprietary Stereo CT technology.
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“Today, fewer than five percent of U.S. patients that need cardiac CT are getting appropriately scanned due to lack of access at point-of-care”, said Arineta CEO Scott Schubert, in a statement. “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 American College of Cardiology and American Hospital Association 2021 guidelines.”

Based in Israel, Arineta scientists are the inventors of the multi-slice spiral CT technology. The Spotlight dedicated cardiovascular and SpotLight Duo cardio-thoracic CT scanners can be used in diagnosis and therapy planning for applications such as calcium scoring, cardiac CTA, and peripheral vascular imaging, including in patients with high or unstable heart rates and those who are obese.

They also can image the entire heart and cardiovascular system with 140 mm coverage at a rotation speed of 0.24 sec per rotation and with less radiation than whole-body CT scanners, and reduce contrast volumes and the need to administer beta blockers.

Because both are used in office, mobile, or cath lab settings, the company’s DLIR software will also be accessible in those environments.

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