FDA Clears CT Scanners for Cardiovascular Assessments

Arineta's Spot Light and Spot Light Duo CT scanners receive FDA approval for cardiovascular assessments.

Highlights:

The FDA has granted 510(k) clearance for Arineta's SpotLight and SpotLight Duo CT scanners, tailored for cardiovascular assessments
The SpotLight system offers impressive features, including high-resolution imaging, as front-line tools for cardiovascular disease diagnosis
With whole organ acquisition and 4D imaging, the SpotLight Duo elevates cardiac imaging, promising improved accuracy and efficiency in cardiovascular assessment

The Food and Drug Administration (FDA) has recently granted 510(k) clearance for the SpotLight and SpotLight Duo computed tomography (CT) scanners, a groundbreaking development by Arineta, specifically designed for cardiovascular assessments.

A New Era in Cardiovascular Assessment

The SpotLight system offers a 25 cm field of view tailored to cardiovascular CT scans, offering a range of impressive features. These include best-in-class specifications for one-beat whole-heart coverage (14 cm), exceptional spatial resolution (0.5 mm detector), and rapid temporal resolution (120 msec).

Arineta proudly claims that the SpotLight systems are the latest addition to their legacy of clinical innovation ().

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‘SpotLight Duo CT scanner offers 45 cm high-resolution scans, enabling comprehensive cardiothoracic CT assessments. #cardiac #ctscans #medindia’

Arineta's CEO, Scott Schubert, emphasizes the company's vision, stating, "Our vision is to grow cardiac CT as the front-line non-invasive test for diagnosing, therapy planning, and monitoring of cardiovascular disease, the number one cause of death and healthcare costs worldwide."

SpotLight Duo: Elevating Cardiac Imaging

In addition to the SpotLight system, Arineta introduces the SpotLight Duo, which takes cardiovascular imaging to the next level. This advanced technology provides whole organ acquisition with 4D imaging, enabling enhanced visualization of vascular flow and organ motion.

With 45 cm high-resolution scans, the SpotLight Duo facilitates comprehensive cardiothoracic CT assessments, covering a range of conditions, from lung cancer and COVID-19 to other pulmonary diseases.

With FDA clearance now in place, the SpotLight and SpotLight Duo CT scanners are poised to empower healthcare professionals with advanced tools for cardiovascular assessments.

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These cutting-edge scanners aim to enhance the accuracy, efficiency, and effectiveness of diagnosing and monitoring cardiovascular diseases, marking a significant advancement in the field of cardiac care.

Reference:

FDA Clears First Major Imaging Device Advancement for Computed Tomography in Nearly a Decade - (https://www.fda.gov/news-events/press-announcements/fda-clears-first-major-imaging-device-advancement-computed-tomography-nearly-decade)

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Source-Medindia

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