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.

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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.

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RSNA and several other industry societies have shared a new expert consensus document on the significant value of cardiac CT. Echo remains an effective first-line imaging option, the groups wrote, but CT can make a big impact as well. 

"Using AI for tasks like CAC detection can help shift medicine from a reactive approach to the proactive prevention of disease," one researcher said.

Former American Society of Echocardiography president and well-known cardiac ultrasound pioneer Roberto Lang, MD, died at the age of 73. He helped develop 3D echo technology that is now used by care teams on a daily basis.