SpotLight/SpotLight Duo (with DLIR option)

by Arineta  · Based in Israel → — The World's First Dedicated Single-Heartbeat, Whole-Heart Cardio-Thoracic CT Scanner
Cardiology Pulmonology Radiology
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Pay-per-use program available; no upfront equipment cost for us healthcare providers.
Regulatory Status Disclosed

Overview

Arineta’s SpotLight and SpotLight Duo are groundbreaking cardiovascular and thoracic CT scanners, revolutionizing cardiac imaging with proprietary Stereo CT technology. These systems are designed to provide comprehensive clinical information for diagnosis, therapy planning, and monitoring of cardiovascular and thoracic diseases. Key features include ultra-fast gantry rotation (0.24 seconds per rotation) for single-heartbeat, whole-heart imaging with 140 mm coverage, and significantly reduced radiation doses compared to traditional whole-body CT scanners. The optional Deep Learning Image Reconstruction (DLIR) technology, powered by artificial intelligence, further enhances image quality by reducing noise while maintaining high-contrast spatial resolution. SpotLight systems can reduce contrast volumes and, in some cases, eliminate the need for beta-blockers. The compact design allows for flexible deployment in various settings, including point-of-care, offices, cath labs, and even mobile units with the Mobile SpotLight Duo.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • World's first dedicated single-heartbeat, whole-heart cardio-thoracic CT scanner
  • Proprietary Stereo CT technology
  • Deep Learning Image Reconstruction (DLIR) for enhanced image quality
  • Low radiation dose compared to whole-body CT scanners
  • Ultra-fast gantry rotation (0.24 sec per rotation)
  • 140 mm coverage for whole heart imaging
  • High-resolution images for accurate diagnosis
  • Small footprint and ultra-short gantry geometry for flexible deployment
  • Ability to reduce contrast volumes and refrain from beta-blockers
  • Mobile SpotLight Duo for point-of-care access

Use Cases

  • Diagnosis and therapy planning for cardiovascular and thoracic diseases
  • Coronary Artery Disease (CAD) assessment and monitoring
  • Cardiac Calcium Scoring
  • CT Angiography (CCTA)
  • Transcatheter Aortic Valve Replacement (TAVR/TAVI) planning
  • Low-Dose Lung Cancer Screening (LDCT)
  • Triple-rule-out studies

What Physicians Need to Know

Cardiac CT Analysis
The SpotLight/SpotLight Duo is a dedicated cardiovascular and thoracic CT scanner, providing high-resolution anatomical images of the heart and coronary arteries. It performs comprehensive cardiac assessments, including structure and function, and is capable of 4D imaging to visualize vascular flow and organ motion. The DLIR (Deep Learning Image Reconstruction) technology, powered by an advanced deep learning convolutional neural network, enhances image quality by significantly reducing noise while maintaining high-contrast spatial resolution.
Coronary Artery Assessment
The system is optimized for calcium scoring and cardiac CT angiography (CCTA), offering motion-free coronary images even with high or unstable heart rates. It supports the quantification of stenosis in coronary arteries and integrates with advanced AI technologies for deeper insights into plaque characteristics, blood flow, and vessel health.
ECG/EKG Analysis Capability
The system utilizes ECG gating for robust cardiac acquisitions, enabling motion-free imaging even in patients with high or irregular heart rates and arrhythmias. Electrode patches are placed on the chest to monitor the heart's electrical activity during the scan.
Arrhythmia Management During Imaging
Designed to improve the robustness of cardiac exams for patients with high or irregular heart rates, including those with irregular heartbeats, arrhythmia, and PVCs, by ensuring diagnostic quality, motion-free images during these challenging conditions.
Heart Failure Risk Prediction Support
The tool is effective for identifying and reducing cardiovascular risk through calcium scoring, which detects plaque buildup. It also supports advanced AI imaging programs that analyze plaque characteristics and blood flow, contributing to personalized cardiovascular risk assessment.
AHA/ACC Guideline Alignment
Arineta's SpotLight systems align with the ACC & AHA 2021 guidelines, which recommend cardiac CT as a Level 1A evidence test for the diagnosis of stable and acute chest pain.
Real-Time Alert Capability
The system includes the ability to define alert values with thresholds and features audit logging and review capabilities, likely for monitoring scan parameters and system performance.
Physician Tip

Arineta's SpotLight/SpotLight Duo, with its DLIR option, offers a dedicated and high-performance cardiac CT solution. Physicians can leverage its ability to acquire motion-free, high-definition coronary images in a single heartbeat, even in patients with challenging heart rates, to achieve precise diagnoses for coronary artery disease, calcium scoring, and TAVR planning. The integration of advanced AI imaging programs provides deeper insights into plaque characteristics and blood flow, enhancing personalized risk assessment and treatment strategies. The DLIR technology significantly improves image quality by reducing noise, allowing for more confident interpretations at lower radiation doses. This system supports a CT-first approach for chest pain evaluation, aligning with current ACC/AHA guidelines, and can be a valuable tool for early detection and preventative care in an office or outpatient setting.

The Arineta SpotLight/SpotLight Duo systems are DICOM conformant, supporting DICOM Storage Service Class, Modality Worklist, secondary capture, and Structured Report services for seamless image interchange and workflow integration. Furthermore, the system is designed to integrate with advanced AI imaging programs such as HeartFlow, Cleerly, and Elucid, which provide physiological analysis of CT images for deeper insights into plaque characteristics, blood flow, and vessel health.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Pay-per-use program available; no upfront equipment cost for us healthcare providers. — Pay-Per-Use program; no upfront equipment cost (US healthcare providers)
DeploymentOn-premise (CT scanner hardware); available for point-of-care, office, mobile, or cath lab settings.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The SpotLight/SpotLight Duo (with DLIR option) received 510(k) clearance (K230370) on October 13, 2023, for X-ray Computed Tomography imaging of cardiovascular and thoracic anatomies. Additionally, the SpotLight Duo received 510(k) clearance for low-dose lung cancer screening (LDCT) (K241200) on January 13, 2025.
Integrations
EHR Not specified
Specialties Cardiology, Pulmonology, Radiology

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Support & Docs
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Press & Coverage

DAIC
Arineta's Cardiac CT Scanner Receives FDA Clearance
Arineta's SpotLight Duo cardiac CT scanner received 510(k) clearance from the U.S. FDA for low-dose lung cancer screening (LDCT), allowing a single platform for both cardiac and lung imaging. The system features deep-learning imaging reconstruction (DLIR) technology to enhance image quality.
2025-05
Arineta
Arineta Secures EU MDR CE Mark for SpotLight and SpotLight Duo Cardiovascular CT Scanners
Arineta announced that its SpotLight and SpotLight Duo cardiac CT scanners received approval under the European Union (EU) Medical Device Regulation 2017/745 (EU MDR), enabling commercialization across Europe. The Duo model offers thoracic imaging for pulmonary conditions in addition to cardiovascular imaging.
2026-03
Arineta
Arineta Receives FDA Clearance for its Deep Learning Image Reconstruction Technology in SpotLightu2122 Cardiovascular CT Scanners
Arineta Cardio Imaging received 510(k) clearance from the U.S. FDA for its deep learning image reconstruction (DLIR) technology for use in its SpotLightu2122 family of cardiovascular CT scanners. This AI-powered technology enhances image quality and reduces noise for cardiac, vascular, and thoracic procedures.
2023-11
AuntMinnieEurope
Arineta gains EU MDR approval for SpotLight cardiac CT scanners
Israel-based Arineta has received EU MDR approval for its SpotLight and SpotLight Duo cardiovascular CT scanners, allowing them to be sold in Europe. The Duo model adds thoracic imaging capabilities for lung cancer and other pulmonary conditions.
2026-04
Arineta
Arineta Expands Cardiac Care in Georgia with Installation of Advanced SpotLightu2122 Duo Scanner at PACE
Arineta announced the installation of its SpotLightu2122 Duo cardiac CT scanner at Peachstate Advanced Cardiac and Endovascular (PACE) in Newnan, Georgia, to meet the growing demand for advanced cardiac diagnostics. The scanner utilizes deep-learning imaging reconstruction (DLIR) for enhanced image clarity.
2024-10
Arineta
Arineta Installs First SpotLight Duo in Rocky Mountain Region at Clear Heart and Lung Imaging
Arineta announced the opening of Clear Heart and Lung Imaging in Loveland, Colorado, featuring the first SpotLightu2122 Duo CT Scanner in the Rocky Mountain region. The scanner uses DLIR technology and offers high-quality cardiac and thoracic imaging.
2024-06
accessdata.fda.gov
SpotLight/SpotLight Duo (with DLIR option) (K230370)
This FDA 510(k) clearance document details the SpotLight/SpotLight Duo (with DLIR option) as a multi-slice, dual-tube CT scanner intended for cardiovascular and thoracic imaging, with DLIR technology enhancing image reconstruction. The document confirms the device's substantial equivalence to its predicate.
2023-10
accessdata.fda.gov
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (K241200)
This FDA 510(k) summary outlines the clearance for the SpotLight/SpotLight Duo with a Low Dose Lung Cancer Screening (LD LCS) option. It notes that while DLIR and ASIR-CV options are not compatible with the LD LCS option, the device is intended for diagnosis and therapy planning for cardiovascular and thoracic anatomies.
2025-01

Videos

Product demos, reviews, and walkthroughs for SpotLight/SpotLight Duo (with DLIR option).

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Frequently Asked Questions

SpotLight/SpotLight Duo with Deep Learning Image Reconstruction (DLIR) significantly improves image quality by reducing noise and artifacts, even at lower radiation doses, which is crucial for patient safety, especially in vulnerable populations like children. This enhanced clarity can lead to more accurate diagnoses, earlier disease detection, and improved confidence in clinical decision-making across various modalities like CT, MRI, and PET/CT.
AI medical imaging solutions, including DLIR, must meet stringent regulatory standards such as FDA clearance in the US and CE marking in Europe, which involves rigorous clinical validation. Data privacy, particularly HIPAA compliance, is a critical factor for broader AI adoption, ensuring patient data is protected throughout the imaging and analysis workflow.
Traditional image reconstruction techniques like Filtered Back Projection (FBP) and Iterative Reconstruction (IR) are common alternatives, but they often suffer from higher noise levels or altered noise texture compared to DLIR. SpotLight/SpotLight Duo's DLIR leverages deep neural networks to intelligently suppress noise while preserving anatomical details, offering superior image quality and potentially lower radiation doses than these conventional methods.
The AI medical imaging market offers evolving pricing models, moving from traditional perpetual licensing to more flexible options like subscription-based SaaS with tiered features or pay-per-analysis models. These models aim to align costs with actual clinical utilization, with total costs encompassing licensing fees, integration, training, and ongoing maintenance.
Limitations of AI in diagnostic imaging include potential biases from insufficient or non-diverse training data, which can lead to inaccuracies for certain patient populations. While AI can enhance efficiency, it is not a substitute for human expertise, and radiologists must maintain oversight as AI algorithms are often narrow in scope and may struggle with outlier cases.
Effective integration of AI solutions like SpotLight/SpotLight Duo with existing Picture Archiving and Communication Systems (PACS) and Radiology Information Systems (RIS) is crucial for seamless workflow. Vendors typically provide IT work and expert services for integration, ensuring the AI solution can process images and contribute to reporting within the current clinical infrastructure.
AI tools like SpotLight/SpotLight Duo are designed to augment, not replace, human clinicians, improving efficiency and accuracy by automating routine tasks and highlighting subtle anomalies. Radiologists will continue to play a crucial role in interpreting images, making complex clinical decisions, and providing patient care, with AI serving as a powerful co-pilot to enhance their capabilities and reduce burnout.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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