X1-FFR
Overview
X1-FFR by SpectraWAVE, Inc. is an AI-enabled, wire-free, and drug-free coronary physiology software designed to calculate fractional flow reserve (FFR) from a single angiogram. Operating as a software application on the HyperVue Imaging System, it integrates physiological assessment and intravascular imaging (DeepOCT+NIRS) onto a single clinical platform.
The software is intended for use by or under the supervision of cardiologists within cardiac catheterization laboratories. It is indicated for patients undergoing transluminal interventional procedures, such as percutaneous coronary intervention (PCI) planning and optimization.
X1-FFR integrates into the clinical workflow by utilizing a direct, real-time angiography feed. This design eliminates the need for invasive pressure wires, hyperemic drugs, and the workflow delays associated with network-based DICOM file transfers. Notable capabilities of the software include:
- Single-View Analysis: Derives FFR values using only one angiographic view per vessel.
- AI-Driven Automation: Automatically performs vessel segmentation and frame suggestion to streamline calculations.
- Vessel Quantification: Measures coronary vessel dimensions, quantifies stenosis, and calculates pressure drops to assist in clinical decision-making.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-enabled, wire-free, drug-free FFR measurement
- Single angiogram derived physiology results
- Rapid and accurate FFR results
- Automated vessel segmentation
- Automated frame suggestion
- Eliminates DICOM file management and transfer delays
- Software add-on to HyperVue Imaging System
- Measurement and reporting tools for coronary vessels
- Quantifies stenosis in coronary vessels
- Quantifies pressure drop in coronary vessels
Use Cases
- Assessing coronary artery disease (CAD)
- Supporting treatment decision making during diagnostic angiograms
- PCI planning and optimization
- Identifying appropriate lesions for revascularization
- Quantifying stenosis in coronary vessels
- Quantifying pressure drop in coronary vessels
What Physicians Need to Know
Leverage X1-FFR's AI-enabled automated vessel segmentation and frame suggestion to streamline FFR assessment and accelerate results in the cath lab. Utilize the wire-free and drug-free approach to reduce procedural complexity, patient discomfort, and overall procedure time. Integrate X1-FFR with the HyperVue Imaging System for a comprehensive platform that combines angiogram-derived physiology with intravascular imaging (DeepOCT+NIRS), enabling more informed PCI planning and optimization. Recognize that this technology provides accurate FFR values from a single angiogram, offering a faster and safer alternative to traditional pressure wire-based methods for assessing coronary artery disease.
X1-FFR functions as a software add-on to SpectraWAVE's HyperVue Imaging System, creating a unified platform that integrates FDA-cleared angiogram-derived physiology with intravascular imaging capabilities (DeepOCT+NIRS). The system is designed for seamless operation within the cath lab, utilizing a direct real-time angiography feed to eliminate delays associated with network-based DICOM file transfers.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | Software add-on to HyperVue Imaging System, typically deployed in cardiac cath labs. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated SpectraWAVE, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance (K251355) for its X1-FFR on October 17, 2025. It is cleared as a software tool that uses X-ray angiographic images to simulate coronary vascular conditions, aiding clinicians in non-invasive assessment of coronary artery disease. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
What the Web Says
SpectraWAVE's X1-FFR is an AI-enabled software that provides rapid, accurate Fractional Flow Reserve (FFR) results from a single angiogram, eliminating the need for wires, drugs, and network-based DICOM file transfer delays. It integrates with the HyperVue Imaging System, creating a comprehensive platform for both angiogram-derived physiology and intravascular imaging. Physicians have expressed enthusiasm for its potential to simplify workflow, reduce user variability, and improve patient safety by offering a less invasive alternative to traditional FFR measurements.
Overall: PositiveStrengths
- Wire-free and drug-free, making it less invasive and potentially safer for patients.
- Provides rapid FFR results, often in less than one minute.
- Requires only a single angiogram view, simplifying the procedure and reducing workflow complexity.
- Utilizes AI for automated vessel segmentation and frame suggestion, enhancing speed and ease of use.
- Eliminates network-based DICOM file management and transfer delays through a direct real-time angiography feed.
- High concordance with invasive hyperemic pressure wire measurements in clinical analysis.
Limitations
- As a single-view method, it may be susceptible to foreshortening errors if the initial angiographic acquisition angle is suboptimal.
- Limited specific validation details and full publication of clinical study results are awaited to scrutinize patient selection and performance in complex anatomical subsets.
- The information available is primarily from press releases and a review article, with no independent user reviews from platforms like Reddit, G2, or Capterra specifically for X1-FFR.
Based on reviews from: SpectraWAVE (spectrawave.com), Diagnostic and Interventional Cardiology (dicardiology.com), CRTonline (crtonline.org), MDPI (mdpi.com), Lumira Ventures (lumiraventures.com), FDA.report (fda.report)
Last updated: 2026-07-19
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Press & Coverage
Videos
Product demos, reviews, and walkthroughs for X1-FFR.
A Breakthrough in Coronary Imaging with Eman Namati CEO at SpectraWAVE
State of MedTech.
