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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.