CINA-iPE

by Avicenna.AI  · Based in France → — Medical Innovation for Enhanced Patient Care.
Emergency Medicine Pulmonology Radiology

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Regulatory Status Disclosed

Overview

CINA-iPE by Avicenna.AI is an advanced AI-powered triage and notification software designed to detect incidental pulmonary embolisms (iPE) on CT scans. This innovative tool analyzes contrast-enhanced CT scans performed for other clinical indications, such as chest, abdomen-pelvis, thoraco-abdominal, or whole-body scans, that include at least a portion of the lungs.

By automatically identifying and flagging unsuspected pulmonary embolisms that might otherwise go unnoticed, CINA-iPE enables radiologists to prioritize urgent cases, accelerate clinical decision-making, and initiate early treatment. This proactive approach helps prevent missed diagnoses, reduce emergency readmissions, and improve overall patient outcomes.

The solution integrates seamlessly into existing radiology workflows, including PACS and RIS, automatically triggering and reporting algorithm results through systems already used by clinicians. It boasts high sensitivity (87.8-91.1%) and specificity (91.8-92%) and is compatible with various CT scanner models from leading manufacturers.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated detection of incidental Pulmonary Embolism (iPE) on CT scans.
  • Triage and prioritization of critical cases.
  • Analyzes various CT scan types (chest, abdomen-pelvis, thoraco-abdominal, whole-body).
  • Seamless integration into existing radiology workflows (PACS, RIS).
  • Rapid processing time (10-60 seconds).
  • High sensitivity (87.8-91.1%) and specificity (91.8-92%).
  • DICOM input/output (DICOM SC, GSPS).
  • Notification and worklist order output.
  • Compatible with multiple CT scanner models and manufacturers.

Use Cases

  • Early detection of unsuspected pulmonary embolisms.
  • Prioritizing urgent patients in radiology workflows.
  • Reducing diagnosis time and accelerating access to treatment.
  • Preventing missed diagnoses and emergency readmissions.
  • Optimizing patient management and care coordination.
  • Supporting radiologists in handling increased workloads.

What Physicians Need to Know

DICOM Support & Standards
CINA-iPE complies with DICOM (Digital Imaging and Communications in Medicine) NEMA PS 3.1 - 3.20, accepting DICOM as input and outputting DICOM SC and GSPS.
PACS Integration Method
The tool seamlessly integrates into existing healthcare systems via global standards such as DICOM, HL7, and FHIR. It supports integration in standard reading environments (PACS) and through AI marketplaces or distribution platforms, automatically triggering and reporting algorithm results within existing radiologist workflows.
Reading Room Workflow Impact
CINA-iPE assists radiologists in workflow triage by flagging and communicating suspected incidental Pulmonary Embolism (iPE), prioritizing cases for urgent review. This can reduce diagnostic delays and missed findings, particularly in oncology patients, with results available within minutes to help prioritize study interpretation. The AI operates in parallel to standard-of-care image interpretation, with clinicians retaining ultimate responsibility for review.
AI Model Architecture
The solution utilizes a deep learning-based algorithm, employing a combination of deep learning and machine learning technologies. The deep learning model was trained end-to-end on 5,429 cases.
Processing Speed (per study)
Processing speed is reported as 1.5 minutes on average (95% CI: 1.4%-1.5%) in one study, and between 10-60 seconds in another source.
FDA Clearance Pathway
CINA-iPE has received FDA 510(k) clearance and is classified as a Class II device.
Supported Modalities
The tool is designed for Contrast-Enhanced CT (CECT) scans, specifically analyzing chest and thoraco-abdominal CT angiographies (CTA) for incidental PE. It can detect lung blood clots in various CT scan types that include at least a portion of the lungs, such as full-body, chest, abdomen and pelvis, and thoraco-abdominal scans.
Sensitivity & Specificity Data
In one study, CINA-iPE demonstrated 87.8% sensitivity and 92.0% specificity for iPE detection on CECT. A later version of the AI model showed 97.3% sensitivity (95% CI: 85.84u201399.93%) and 97.74% specificity (95% CI: 97.14u201398.24%). The tool was validated on 381 CT scans from 39 different scanner models across five manufacturers, achieving 'excellent sensitivity and specificity'.
RSNA/ACR Validation
While specific RSNA/ACR validation programs are not explicitly mentioned, the tool has been subject to multicenter, multivendor studies and clinical publications presented at conferences such as ATS Congress and European Congress of Radiology, demonstrating thorough clinical validation.
Physician Tip

CINA-iPE is a valuable triage and notification tool for detecting incidental pulmonary embolisms on routine CT scans, particularly in non-dedicated PE protocols. It can significantly enhance workflow efficiency by prioritizing critical cases, potentially reducing diagnostic delays and improving patient outcomes. Physicians should remember that the AI serves as an assistive tool, and final diagnostic responsibility remains with the interpreting clinician. Leverage the rapid alerts to expedite review of flagged studies, especially in high-risk populations like oncology patients. Be aware that the device is not designed to detect PE in subsegmental arteries.

CINA-iPE is designed for seamless integration into existing clinical workflows and IT infrastructure. It supports DICOM, HL7, and FHIR standards for interoperability. Deployment options include cloud-based, local dedicated hardware, or locally virtualized environments (VM, Docker). It can be integrated directly with PACS systems or through AI marketplaces and distribution platforms like TeraRecon's Eureka Clinical AI, deepcOSu00ae, Blackford Analysis, CARPL.AI, Incepto, Philips Healthcare, Sectra, and Viz.ai One. This flexibility aims to minimize disruption and simplify IT operations.

Details

Category Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Subscription
  • Subscription; Based on: Number of analyses, Number of installations; Annual or multi-year agreements
DeploymentCloud-based, Locally on dedicated hardware, Locally virtualized (virtual machine, Docker).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

CINA-iPE received 510(k) clearance from the US Food and Drug Administration on March 13, 2024 (K233968). It is a radiological computer-aided triage and notification software indicated for incidental Pulmonary Embolism (iPE) detection on contrast-enhanced CT scans.

Integrations
EHR Not specified
Specialties Emergency Medicine, Pulmonology, Radiology

What the Web Says

CINA-iPE by Avicenna.AI is an FDA-cleared and CE-marked AI-powered tool designed to detect incidental pulmonary embolisms (iPEs) on contrast-enhanced CT (CECT) scans performed for other clinical indications. It aims to improve the detection rate of iPEs, which are often overlooked in routine CT scans, particularly in oncology patients where they can be a significant cause of mortality. The software integrates into existing clinical workflows, providing rapid analysis and notification to help prioritize cases for interpretation.

Overall: Positive

Strengths

  • High sensitivity and specificity in detecting iPEs, with studies reporting sensitivity as high as 97.3% and specificity up to 97.74%.
  • Rapid processing time, with results available to physicians within minutes (average of 1.5 minutes).
  • Aids in early detection and treatment of iPEs, potentially improving patient outcomes and reducing delayed care.
  • Validated across a wide range of CT scanner models from multiple manufacturers, ensuring broad compatibility.
  • Reduces the rate of missed pulmonary embolisms, acting as an effective safety net for radiologists.
  • Particularly beneficial for vulnerable patient populations, such as oncology patients, where iPEs are a significant concern.

Limitations

  • Some false positives have been observed, with common causes including artifacts and lymph nodes.
  • While diagnostic accuracy is high, the direct impact on clinical workflow efficiency and cost-effectiveness requires further prospective trials.
  • The device missed some pulmonary embolisms, with a percentage of these being complex cases subject to disagreement among reviewers.
  • The prevalence of iPE can be low in some study populations, which might affect the positive predictive value.
  • Differences in CT scanner models and reconstruction methods may potentially reduce the accuracy of detecting iPE.

Based on reviews from: Radiology Advances, Avicenna.AI, BioWorld, Xtalks, Applied Radiology, Sectra Amplifier Marketplace, Blackford Analysis, PubMed, G2, Capterra, Reddit

Last updated: 2026-07-21

Ratings & Reviews

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Press & Coverage

PharmExec
FDA Grants 501(k) to Two Avicenna.AI Products | PharmExec
Avicenna.AI received FDA 510(k) clearance for its CINA-iPE and CINA-ASPECTS AI products, designed to detect incidental pulmonary embolism and assess stroke severity during CT scans, respectively. CINA-iPE aims to improve the reporting of unsuspected pulmonary embolisms, which are often missed in initial reports.
2024-03
Venous News
FDA clears AI-driven detection tool for pulmonary embolism - Venous News
Avicenna.AI announced FDA 510(k) clearance for its CINA-iPE, an AI-powered tool that identifies incidental pulmonary embolism (PE) during routine CT scans. The company highlighted CINA-iPE's excellent sensitivity and specificity in validation studies, demonstrating its ability to prioritize and triage cases effectively.
2024-03
PR Newswire
Avicenna.AI secures FDA clearance for two healthcare AI solutions - PR Newswire
Avicenna.AI announced FDA 510(k) clearance for its CINA-iPE and CINA-ASPECTS AI solutions, which use deep learning to detect and prioritize life-threatening conditions from CT images. CINA-iPE specifically targets incidental pulmonary embolism, a common finding often missed in initial interpretations.
2024-03
Diagnostic Imaging
FDA Clears CT-Based AI Tools for PE Detection and Stroke Severity Assessment
The FDA granted 510(k) clearance to Avicenna.AI's CINA-iPE and CINA-ASPECTS, AI modalities designed to improve the detection of incidental pulmonary embolism and enhance stroke severity evaluation from CT scans. CINA-iPE was validated on 381 CT scans and showed strong sensitivity and specificity for incidental PE diagnosis.
2024-03
Vascular News
Avicenna.AI secures European MDR certification for AI medical imaging portfolio
Avicenna.AI has achieved European MDR certification for its AI tools, including CINA-iPE for opportunistic pulmonary embolism detection. This certification, alongside existing FDA clearances, demonstrates the company's commitment to high standards in medical device safety and performance.
2024-07
Viz.ai
Viz.ai Integrates Avicenna.AIu2019s Tools for ASPECTS Stroke Severity Assessment and Incidental Pulmonary Embolism into Viz.ai One Platform
Viz.ai is integrating Avicenna.AI's CINA-iPE and CINA-ASPECTS tools into its Viz.ai One platform to enhance neurovascular patient care. CINA-iPE detects incidental pulmonary embolism during routine CT scans, aiming to address delayed and missed findings.
2024-12
PMC (PubMed Central)
Contribution of an Artificial Intelligence Tool in the Detection of Incidental Pulmonary Embolism on Oncology Assessment Scans - PMC
This study evaluates the accuracy of the CINA-iPE AI algorithm in detecting incidental pulmonary embolism (iPE) in cancer patients undergoing routine CT scans. The research highlights CINA-iPE's high sensitivity and specificity in identifying iPEs that might otherwise be overlooked.
2024-09
Radiology Advances
Deep learning-based algorithm for automatic detection of incidental pulmonary embolism on contrast-enhanced CT: a multicenter multivendor study | Radiology Advances | Oxford Academic
This study evaluates the diagnostic performance of the CINA-iPE deep learning algorithm for automatic detection of incidental pulmonary embolism on contrast-enhanced CT scans. The algorithm demonstrated high sensitivity and specificity, with rapid processing times, suggesting its utility in prioritizing exams for iPE detection.
2025-07

Videos

Product demos, reviews, and walkthroughs for CINA-iPE.

View all on YouTube

Frequently Asked Questions

CINA-iPE is an AI-powered triage and notification software that seamlessly integrates into existing clinical workflows, such as PACS systems. Its primary function is to automatically analyze various CT scans (chest, abdomen-pelvis, thoraco-abdominal, or whole-body) for unsuspected pulmonary embolisms (PE) and flag suspected cases, providing results within seconds to minutes.
CINA-iPE is FDA-cleared (510(k) Class II) in the U.S. and CE-marked (Class IIb) in Europe, indicating its compliance with stringent medical device regulations. It is designed according to the EN ISO 13485 Quality management system and complies with DICOM standards for interoperability, integrating securely within hospital radiology departments.
While CINA-iPE demonstrates high sensitivity (87.8-97.3%) and specificity (92.0-97.74%) for detecting incidental PE, it is a triage and notification tool, not a standalone diagnostic device. False positives can occur due to factors like artifacts or lymph nodes, and clinicians remain ultimately responsible for reviewing full images and making final diagnoses.
CINA-iPE is noted as one of the few available AI solutions for incidental PE detection on the market. It differentiates itself by its ability to detect incidental PE across various CT scan types, including those performed for other conditions, and its seamless integration into existing radiology workflows to prioritize critical cases.
CINA-iPE is generally offered under a subscription-based pricing model. The cost can be determined by factors such as the number of analyses performed or the number of installations required within a healthcare institution.
CINA-iPE improves patient outcomes by preventing missed diagnoses of incidental PE, enabling earlier treatment, and potentially reducing emergency readmissions. For workflow efficiency, it prioritizes critical cases, accelerates clinical decision-making by providing rapid alerts, and enhances care coordination.
CINA-iPE is designed for seamless integration into standard reading environments like PACS, supporting DICOM input and output formats. Deployment options include cloud-based, locally on dedicated hardware, or locally virtualized (e.g., via virtual machine or Docker), with Avicenna.AI and its partners providing integration and support.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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