FDA grants 510(k) clearance to cardiac CT scanner

The FDA granted a 510(k) clearance on Aug. 10 to Arineta’s SpotLight CT scanner.

Arineta, which is based in Israel, said in a news release that imaging experts and cardiologists designed the cardiovascular-dedicated SpotLight CT scanner.

Arineta has initiated an observational, prospective study to assess the image quality, diagnostic accuracy and predictive value of the SpotLight CT scanner in patients with suspected cardiac disease. The study began enrolling patients in January and is expected to last until November 2022.

Arineta signed an agreement with GE Healthcare, which will market the SpotLight CT scanner to cardiology clinics and hospitals, according to Globes, an Israeli financial newspaper.

Ehud Dafni, PhD, Arineta’s CEO and cofounder, told Globes that doctors in the U.S. have expressed interest in using the SpotLight CT scanner. He expects to sign agreements with clinics and hospitals this year or early next year.

Dafni added that GE Healthcare would receive royalties for each SpotLight CT scanner sale.