DEEPVESSEL FFR

by Keya Medical  · Based in China → — Fast and accurate non-invasive deep learning-based CT FFR analysis.
Cardiology Radiology
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Regulatory Status Disclosed

Overview

DEEPVESSEL FFR (DVFFR) is a software medical device that utilizes deep learning technology to perform a non-invasive physiological functional assessment of the coronary arteries using coronary computed tomography angiography (CCTA) scans. It processes CCTA images semi-automatically, generating a three-dimensional model of the coronary artery tree and estimating CT-derived fractional flow reserve (FFR) values. This analysis is intended to support the functional evaluation of coronary artery disease (CAD) and aid in treatment decisions.

The software applies Keya Medical’s proprietary deep learning technologies, built on advancements in computer vision and medical image analysis, to integrate key technologies in artificial intelligence, medical imaging, and biomedical engineering. This approach aims to improve diagnostic accuracy, robustness of segmentation, and processing speed. DEEPVESSEL FFR can help clinicians assess myocardial ischemia caused by coronary artery stenosis without the need for invasive procedures, potentially reducing unnecessary invasive coronary angiography and stent implantation.

The results, including an interactive 3D model of the coronary arteries and a PDF report with mapped FFR values, are electronically delivered to clinicians and can be viewed on PCs, tablets, and mobile devices. It is clinically applicable to patients with stable coronary heart disease (SCAD) with 30-90% coronary stenosis based on CTA examination.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Non-invasive FFR calculation from CCTA images
  • Deep learning technology for analysis
  • Generation of 3D coronary artery tree model
  • Quantitative analysis of myocardial ischemia
  • Auxiliary assessment for treatment decisions and intervention effects
  • Functional assessment without adenosine and pressure guide wire
  • Fast processing speed and accurate FFR analysis
  • Comprehensive FFR values at any location in the coronary tree
  • Electronic delivery of interactive 3D model and PDF report
  • Applicable for stable CAD patients with 30-90% stenosis

Use Cases

  • Functional evaluation of Coronary Artery Disease (CAD)
  • Diagnosis of vessel-specific ischemia
  • Guiding decision-making for coronary revascularization
  • Reducing unnecessary invasive coronary angiography procedures
  • Reducing unnecessary stent implantation for CAD diagnosis and treatment
  • Triage of patients with chest pain and suspected CAD

What Physicians Need to Know

Cardiac CT/MRI Analysis
DEEPVESSEL FFR is a software medical device that utilizes deep learning technology to perform non-invasive physiological functional assessment of coronary arteries using Coronary Computed Tomography Angiography (CCTA). It extracts three-dimensional coronary tree structures and generates CT-derived Fractional Flow Reserve (FFR) values from CCTA images.
Coronary Artery Assessment
The tool provides a non-invasive functional assessment of coronary arteries, calculating FFR values at any point in the coronary tree to identify myocardial ischemia in patients with stable coronary artery disease (SCAD) with 30-90% coronary stenosis. It offers both anatomical and functional information to aid clinical decision-making.
AHA/ACC Guideline Alignment
The 2021 ACC and AHA Guidelines for the Evaluation and Diagnosis of Chest Pain highlight the use of Coronary CTA + FFR CT as a front-line pathway for diagnosing vessel-specific ischemia. A new Category I CPT code (75580) for non-invasive FFR estimates derived from coronary CT angiography software analysis was jointly proposed by the ACC, American College of Radiology (ACR), and the Society of Cardiovascular Computed Tomography (SCCT), effective January 1, 2024.
Diagnostic Accuracy
Clinical validation studies, including prospective and retrospective multicenter trials, have demonstrated that DEEPVESSEL FFR yields good diagnostic performance with high accuracy (reported as 90% diagnostic accuracy using invasive FFR as the ground truth) in detecting ischemic conditions.
Efficiency and Workflow
The deep learning-based approach offers fast processing speed and rapid results, with analysis accessible on stationary or mobile devices. The workflow involves sending CCTA to Keya Medical for AI algorithms and certified analysts to perform the DV FFR analysis, with an interactive 3D model and PDF report delivered electronically to clinicians.
Physician Tip

DEEPVESSEL FFR offers a valuable non-invasive option for assessing the functional significance of coronary artery stenosis, particularly in patients with stable coronary artery disease and intermediate stenosis (30-90%). It can help guide revascularization decisions and potentially reduce the need for unnecessary invasive procedures. Physicians should integrate the comprehensive anatomical and functional information provided by the 3D models and FFR reports with the patient's clinical history, symptoms, and other diagnostic tests for optimal decision-making. The accessibility of results on various devices supports a streamlined workflow.

The DEEPVESSEL FFR system integrates with existing Coronary Computed Tomography Angiography (CCTA) image acquisition workflows. CCTA DICOM data is sent to Keya Medical for AI-powered analysis. The analysis results, including interactive 3D models and PDF reports, are delivered electronically through secure servers, such as Ambra Intelerad's AWS platforms, to clinicians.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentSoftware medical device; results delivered electronically via cloud-based processing.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

DEEPVESSEL FFR received U.S. FDA clearance (K213657) on April 1, 2022. It is classified as a Class II Coronary Vascular Physiologic Simulation Software Device (Product Code PJA).
Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

DEEPVESSEL FFR by Keya Medical is an AI-powered software that non-invasively assesses coronary artery disease (CAD) by calculating fractional flow reserve (FFR) values from coronary CT angiography (CCTA) images. It aims to reduce the need for invasive procedures like traditional catheter-based FFR measurements. The software has received FDA clearance in 2022 and regulatory approvals in the EU and China, and is increasingly used in clinical practice worldwide.

Overall: Positive

Strengths

  • Non-invasive assessment of CAD, reducing the need for invasive angiography and stent implantation.
  • High diagnostic accuracy (around 87-90%) compared to invasive FFR as the reference standard.
  • Utilizes deep learning technology for efficient and precise FFR analysis.
  • Provides comprehensive anatomical and functional information throughout the coronary tree.
  • Streamlined workflow with rapid results for timely decision-making.
  • Supported by clinical guidelines (2021 AHA/ACC Chest Pain Guidelines) recognizing the role of CCTA + FFR CT.

Limitations

  • Some physicians on Reddit note variability in FFR measurements and inter-reader variability with CT scans in general.
  • The accuracy of CT-FFR can be overestimated, and calcification in plaques may lead to overestimation of stenosis due to blooming artifact.
  • While FFR is used regularly in some labs, other invasive imaging techniques like IVUS are also frequently employed for stent sizing.
  • One study indicated that on-site CT-FFR using machine learning increased revascularization overall without improving symptoms or quality of life or reducing major adverse cardiovascular events.

Based on reviews from: KeyaMedical (Recent Peer-Reviewed Publications), Diagnostic Imaging, Journal of Geriatric Cardiology : JGC (via PMC), KeyaMedical (Clinical Validation of DEEPVESSELu00ae FFR), KeyaMedical (Testimonials), Keya Medical (DeepVesselu00ae FFR Product Page), Keya Medical (Deep Learning-based CT-FFR: A Gatekeeper to the Cath Lab), PubMed (Diagnostic accuracy of a deep learning approach to calculate FFR from coronary CT angiography), Intellimed Healthcare, AuntMinnie, Keya Medical (DEEPVESSEL CT FFR Analysis), PIA Medical, Keya Medical (Keya Medical's CT FFR analysis DEEPVESSELu00ae is now available in the USA.), ResearchGate (Diagnostic accuracy of a deep learning approach to calculate FFR from coronary CT angiography), ClinicalTrials.Veeva (The ADAPT Study), Reddit (r/Cardiology), Reddit (r/askCardiology), Reddit (r/medicine), Reddit (r/Cholesterol)

Last updated: 2026-07-20

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Press & Coverage

Keya Medical
Keya Medical's CT FFR analysis DEEPVESSELu00ae is now available in the USA.
Keya Medical announced that its deep-learning-based CT FFR, DEEPVESSEL FFR (DVFFR), is now available for clinical use in the USA, having received FDA Clearance, CE Mark, and NMPA Approval. This non-invasive test helps diagnose and treat heart disease with accuracy similar to invasive procedures.
2023-01
Keya Medical
DEEPVESSEL FFR Achieves Global Milestone with Four Certifications
Keya Medical's DEEPVESSEL FFR has achieved a global milestone by obtaining four certifications: China's NMPA, EU CE, US FDA, and Singapore HSA, making it the world's first CT-FFR product to do so. This signifies its adherence to strict safety and effectiveness standards and expands its global market access.
2024-01
Diagnostic Imaging
Could an Emerging Deep Learning Modality Enhance CCTA Assessment of Coronary Artery Disease?
Keya Medical has launched DeepVessel FFR, an FDA-cleared software that uses deep learning to provide non-invasive fractional flow reserve (FFR) assessment from CCTA images. This technology aims to improve diagnostic accuracy for coronary artery disease and potentially reduce the need for invasive procedures.
2023-01
Keya Medical
DEEPVESSEL FFR, Keya Medical Deep-Learning Based, Non-Invasive Coronary Artery Functional Assessment Software Device, Receives FDA Clearance.
Keya Medical announced that its DEEPVESSEL FFR (DVFFR) software received FDA clearance on April 1, 2022. This deep-learning-based software provides a non-invasive physiological functional assessment of coronary arteries using CTA scans, aiming to reduce unnecessary invasive procedures.
2022-04
Journal of Geriatric Cardiology : JGC
Diagnostic accuracy of a deep learning approach to calculate FFR from coronary CT angiography
A single-center, prospective study evaluated the diagnostic performance of DEEPVESSEL-FFR in 63 patients, demonstrating good correlation with invasive FFR measurements and improved diagnostic performance for ischemia-related lesions compared to CTA stenosis severity alone.
2019-01
Keya Medical
Advancing CCTA-Based Cardiovascular Care with Deep Learning: Highlights from Keya Medical's SCCT 2025 Symposium
At SCCT 2025, Keya Medical's symposium highlighted the TRIPLE FFR study, which showed DeepVessel FFR matched HeartFlow FFRct in diagnostic performance when compared against invasive instantaneous wave-free ratio (iFR) in patients with intermediate stenosis.
2025-08
Keya Medical
Kanbai Tech adds CT-FFR to its AI medical imaging platform.
Keya Medical has partnered with Kanbai Tech to integrate DEEPVESSEL FFR into Kanbai Tech's AI medical imaging platform, expanding the availability of this non-invasive CT-FFR technology in Spain. This collaboration aims to enhance diagnostic precision and patient safety in cardiovascular imaging.
2024-07
American Heart Association Journals
Diagnostic Performance of Two CCTA Derived Noninvasive FFR Techniques: The TripleFFR Study
The TripleFFR study, published in Circulation: Cardiovascular Imaging, provided the first head-to-head comparison of HeartFlow FFRct and Keya DeepVessel FFR against invasive instantaneous wave-free ratio (iFR). The study found similar diagnostic accuracy and discrimination for both CT-FFR platforms in detecting hemodynamically significant disease.
2026-05

Videos

Product demos, reviews, and walkthroughs for DEEPVESSEL FFR.

View all on YouTube

Frequently Asked Questions

DEEPVESSEL FFR is a software medical device that non-invasively assesses coronary artery function using deep learning technology applied to existing Coronary Computed Tomography Angiography (CCTA) images. The software processes CCTA images semi-automatically to generate a 3D model of the coronary artery tree and calculates FFR values, delivering an interactive 3D model and PDF report electronically to physicians. This streamlined process aims to provide both anatomical and functional information to improve clinical decision-making and potentially reduce unnecessary invasive procedures.
DEEPVESSEL FFR has received significant regulatory approvals, including FDA Clearance in the US, CE Mark in the EU, NMPA approval in China, and HSA certification in Singapore, making it the first CT-FFR product with these four certifications. For data privacy, the analysis typically involves uploading and de-identification of DICOM data on secure platforms, such as Ambra's US-based AWS servers, before transfer to Keya Medical for analysis, with results delivered back electronically through these secure channels.
DEEPVESSEL FFR has demonstrated high diagnostic accuracy, with per-patient accuracy reported around 85.2-90.3% and per-vessel accuracy around 86.8-90.8% when compared to invasive FFR as the reference standard. Known limitations include that some studies have involved a relatively small number of patients, which may incur selection bias, and the performance was compared against invasive FFR measurements only for vessels with measured values, without evaluating patient outcomes in some trials.
DEEPVESSEL FFR offers a non-invasive functional assessment from CCTA scans, providing an alternative to traditional invasive FFR measurements which require a guidewire-based cardiac catheter procedure. It aims to improve diagnostic performance in determining ischemia-related lesions compared to CCTA alone and can potentially reduce the need for invasive coronary angiography.
Effective January 1, 2024, a new Category I CPT code (75580) was implemented for non-invasive FFR estimates derived from coronary CT angiography software analysis, replacing prior Category III codes. This change, jointly proposed by leading cardiology and radiology societies, signifies its consistent integration into medical practice and has led to increased reimbursement for FFR-CT services in both hospital and physician office settings, potentially optimizing hospital resources by reducing unnecessary invasive procedures.
DEEPVESSEL FFR utilizes proprietary deep learning technology, built on advancements in computer vision and medical image analysis, to process CCTA images and calculate FFR values. The system generates a PDF report and an interactive 3D heart model, which are delivered electronically to physicians, and results can be viewed on various devices. While the software performs the complex analysis, physicians interpret the generated FFR values and reports to aid in their clinical decision-making, with the system designed for easy integration into existing workflows without requiring extensive staff training or scanner certification.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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