FDA clears cardiac CT scanner for low-dose lung cancer screening
The U.S. Food and Drug Administration has just cleared a cardiac CT scanner for expanded use in lung cancer screenings.
Israel-based Arineta—a company that specializes in cardiac CT imaging solutions—announced the 510(k) clearance of its SpotLight Duo cardiac CT scanner on Monday, touting the machine’s ability to complete both cardiovascular and lung cancer screenings in one single ultra-fast scan. It is the company’s hope that the new clearance can improve uptake of low dose CT (LDCT) lung cancer screening exams, which have been historically underutilized.
“This clearance marks a significant milestone in expanding our role in early detection and preventative care,” CEO of Arineta, Doug Ryan, said in a release on the announcement. “We are dedicated to growing cardio-thoracic CT as the front-line non-invasive test for diagnosing, therapy planning, and monitoring of cardiovascular and thoracic disease.”
The scanner can complete two life-saving imaging acquisitions with a single pass. With 140 mm coverage at a rotation speed of 0.24 sec per rotation, the scanner captures diagnostic images of the entire heart in just a single beat. The quick scan reduces the volume of contrast media required to acquire diagnostic images while also minimizing patients’ radiation exposure. It makes use of deep learning reconstruction techniques to enhance the quality of cardiac images, plaque analyses, treatment planning and monitoring cardiovascular disease.
The company believes the scanner is capable of improving access to critical health screenings since it can be used in multiple settings, including mobile trailers. What’s more, Arineta also offers multiple payment options for organizations hoping to get started or expand their footprint into cardiac and lung cancer screening settings.
"The addition of FDA clearance for Low Dose Lung Cancer CT strengthens our ability to support improved outcomes for patients at high risk of disease,” Ryan said in the same release.
Learn more about the scanner here.