Rapid ASPECTS
by RapidAI
· Based in United States →
— AI beyond the algorithm™
Annual subscription model; pricing varies by region, hospital type, modules, and imaging modalities. starts at approximately $12,000 for a single module in the united states.
Regulatory Status Disclosed
Overview
Rapid ASPECTS, developed by iSchemaView (now operating as RapidAI), is a computer-aided diagnosis (CADx) software device designed to assist clinicians in the assessment and characterization of brain tissue abnormalities using CT image data. It automatically registers images, segments, and analyzes ASPECTS (Alberta Stroke Program Early CT Score) Regions of Interest (ROIs). The software extracts image data for these ROIs to provide analysis and computer analytics based on morphological characteristics. An artificial intelligence algorithm then synthesizes these features into a single ASPECT Score. Rapid ASPECTS is indicated for the evaluation of adult patients presenting for diagnostic imaging workup with known Middle Cerebral Artery (MCA) or Internal Carotid Artery (ICA) occlusion, to assess the extent of disease. It provides information useful in characterizing early ischemic brain tissue injury during image interpretation, typically within 6 hours. The tool aims to improve clinician diagnostic accuracy, increase reader reliability, and reduce intra-reader variability, ultimately helping physicians make faster clinical decisions for patients with large vessel occlusions (LVOs) and determine eligibility for thrombectomy.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated ASPECTS score generation for non-contrast CT scans
- Visualization of regions of asymmetry and ischemic change
- Improved clinician diagnostic accuracy (shown to improve by 10%)
- Increased reader reliability and reduced intra-reader variability
- Fast results delivery (under 2 minutes)
- Assists in determining thrombectomy eligibility
- Utilizes clinically validated machine-learning algorithms
- Creates high-quality images from non-contrast CT studies
- Delivers results via PACS, email, and mobile/web applications
- Provides comparative analysis to the ASPECTS standard of care radiologist assessment
Use Cases
- Assessment and characterization of brain tissue abnormalities using CT image data
- Evaluation of adult patients with known MCA or ICA occlusion
- Determining eligibility for mechanical thrombectomy in stroke patients
- Expediting time between CT and CTA scans with prompt LVO notifications (as part of the RapidAI platform)
- Improving patient outcomes in acute stroke care through faster interventions
- Aiding in patient selection for stroke clinical trials (e.g., DAWN and DEFUSE 3)
What Physicians Need to Know
Evidence Base
Rapid ASPECTS is built upon the established Alberta Stroke Program Early CT Score (ASPECTS) guidelines. It employs a validated machine-learning algorithm to automatically score non-contrast CT (NCCT) brain images.
Clinical Validation Studies
Rapid ASPECTS has received FDA clearance as the first neuroimaging analysis device in the CADx (computer-assisted diagnostic software) category. Clinical research studies demonstrate that it improves the accuracy of ASPECT score calculation, particularly for less experienced readers, and leads to higher inter-reader agreement rates. Performance validation testing confirmed that the module met all design requirements and specifications, showing an 82.8% agreement with a reference standard at both the ASPECTS region and scan level.
Alert Fatigue Management
No specific information regarding alert fatigue management features directly within Rapid ASPECTS was found in the provided literature.
Differential Diagnosis Support
Rapid ASPECTS primarily assists in the assessment and characterization of early ischemic brain tissue abnormalities by providing an automated ASPECT score. This aids in identifying areas of irreversible brain injury and helps determine patient eligibility for thrombectomy.
Guideline Update Frequency
The results generated by Rapid ASPECTS are based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines. The underlying machine learning algorithms are described as 'static' after development, operating based on pre-established rules and training data, distinguishing them from dynamic algorithms that continuously learn. However, AI systems are generally expected to incorporate feedback and continuously improve.
Clinical Workflow Integration
Rapid ASPECTS is designed for integration into existing radiology workflows and IT systems, including Picture Archiving and Communication Systems (PACS). It aims to streamline triage and transfer decisions by providing fast, automated analysis and delivering results within minutes of a scan.
Decision Audit Trail
No specific information regarding a 'Decision Audit Trail' feature within Rapid ASPECTS was found in the provided literature.
Physician Tip
Utilize Rapid ASPECTS as an adjunct tool to enhance the accuracy of ASPECT scoring, especially for non-neuroradiologists, and to improve inter-reader agreement. Leverage its automated, rapid analysis of NCCT scans to expedite triage and transfer decisions for acute ischemic stroke patients, aiding in timely thrombectomy eligibility assessment. Remember that while the tool provides a standardized score, clinical judgment and review of original imaging remain paramount.
Rapid ASPECTS is designed to integrate seamlessly with existing hospital IT infrastructure and radiology workflows, including PACS, to facilitate efficient image processing and result dissemination.
Details
| Category | Neurology AI, Radiology & Imaging AI |
| Pricing |
Annual subscription model; pricing varies by region, hospital type, modules, and imaging modalities. starts at approximately $12,000 for a single module in the united states.
|
| Deployment | Software as a Medical Device (SaMD), delivered via PACS, email, and mobile/web applications (cloud-based). |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated Rapid ASPECTS (v3) received FDA 510(k) clearance (K232156) on January 19, 2024, as a Class II computer-aided diagnosis (CADx) software device. |
| Integrations | |
| EHR | Not specified |
| Specialties | Emergency Medicine, Neurology, Radiology |
What the Web Says
Rapid ASPECTS is an AI-powered neuroimaging analysis device designed to assist physicians in evaluating non-contrast CT (NCCT) scans for acute ischemic stroke. It uses a machine-learning algorithm to automatically identify brain regions and generate an Alberta Stroke Program Early CT Score (ASPECTS), aiming to standardize assessment and improve diagnostic accuracy, especially for less experienced readers. The software is intended to help with faster triage, transfer decisions, and determining thrombectomy eligibility.
Overall: PositiveStrengths
- Improves ASPECT scoring accuracy for non-neuroradiologists, making their scores comparable to experts.
- Increases inter-reader agreement rates for ASPECT scoring.
- Automates and standardizes the ASPECT scoring process, aiding in faster triage and transfer decisions.
- Helps physicians quickly identify areas of irreversible brain injury and determine thrombectomy eligibility.
- First and only neuroimaging device with FDA CADx clearance shown to improve reader's scoring.
- Provides fast measurements utilizing a validated machine-learning algorithm.
Limitations
- Not intended for primary interpretation of CT images; it is used to assist physician evaluation.
- Validated primarily in patients with known MCA or ICA occlusion prior to ASPECT scoring.
- No identified evidence on the effects of RapidAI on many important clinical outcomes, including patient harms, mortality, health-related quality of life, length of hospital stay, or healthcare resource implications.
- Cost-effectiveness is currently unknown.
- AI systems require physician review and confirmation of diagnosis; they do not make independent treatment decisions.
Based on reviews from: RapidAI, NeuroNews International, BioSpace, Articsledge, NCBI Bookshelf, accessdata.fda.gov, American Heart Association Journals
Last updated: 2026-07-19
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Press & Coverage
NeuroNews International
Rapid ASPECTS receives CADx clearance from the FDA
Rapid ASPECTS received US FDA clearance as the first neuroimaging analysis device in the CADx category, improving physicians' interpretations of non-contrast CT scans for stroke using a standardized ASPECT score. This AI-powered solution helps stroke teams quickly assess patient eligibility for thrombectomy.
2020-07
RapidAI
Rapid ASPECTS First Neuroimaging Solution with CADx FDA Clearance
RapidAI announced that Rapid ASPECTS received FDA clearance as the first neuroimaging analysis device in the CADx category, designed to improve physicians' interpretations of Non-Contrast CT scans for stroke. The AI-powered solution uses a machine-learning algorithm to identify brain regions and generate an ASPECT score.
2020-06
RapidAI
RapidAI Expands AI-powered Vascular Imaging Globally
RapidAI announced significant 2020 milestones, including the global expansion of its AI-powered vascular imaging solutions and the FDA clearance of Rapid ASPECTS as the first neuroimaging analysis device in the CADx category. The company's technology is now used in over 1,800 hospitals across 60 countries.
2021-03
Practical Neurology
FDA Clears Automated ASPECTS Scoring from CT
The FDA cleared Rapid ASPECTS, a neuroimaging analysis device, as the first in the computer-assisted diagnostic software (CADx) category to assist physicians in interpreting noncontrast CT scans for stroke. The device uses a machine-learning algorithm to generate an ASPECTS score, aiding in the identification of irreversible brain injury.
2020-07
RapidAI
ASPECTS Software Aids Non-Neuroradiologists & Improves ASPECT Scoring
A study published in the Journal of Stroke and Cerebrovascular Diseases showed that Rapid ASPECTS software significantly improved ASPECT scoring by non-neuroradiologists on non-contrast CT scans. The software led to higher inter-reader agreement rates and scores comparable to expert neuroradiologists.
2021-08
BioWorld
AI-powered stroke imaging solution nabs CADx clearance
RapidAI received FDA clearance for Rapid ASPECTS, making it the first neuroimaging analysis device in the computer-assisted diagnostic software category. The system uses a machine-learning algorithm based on the ASPECTS system to identify early signs of brain infarction on noncontrast CT scans.
2020-07
Stroke - American Heart Association Journals
Automated Calculation of Alberta Stroke Program Early CT Score
This study compared the Alberta Stroke Program Early CT Score (ASPECTS) calculated by Rapid ASPECTS software with clinician scores, finding that the automated tool was more highly correlated to DWI volumes and better at identifying patients with low ASPECTS. The findings suggest Rapid ASPECTS can help identify more eligible patients for clinical trials.
2019-09
RapidAI
The Impact of Automated Software on Alberta Stroke Program Early CT Score
A retrospective study indicated that Rapid ASPECTS significantly improved the uniformity and accuracy of ASPECT scoring on non-contrast CT scans for acute ischemic stroke patients. The software's assistance led to improved agreement among readers and enhanced overall accuracy.
2023-10
Videos
Product demos, reviews, and walkthroughs for Rapid ASPECTS.
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Frequently Asked Questions
Rapid ASPECTS is an AI-powered neuroimaging solution that automatically calculates the Alberta Stroke Program Early CT Score (ASPECTS) from non-contrast CT scans, aiding in thrombectomy eligibility assessment. It integrates into existing radiology workflows, delivering standardized scores and annotated images within minutes via PACS, email, and mobile/web apps, streamlining rapid decision-making for stroke teams.
Rapid ASPECTS is the first neuroimaging AI solution cleared by the FDA as a CADx device shown to improve clinician diagnostic accuracy, particularly for non-neuroradiologists. It standardizes the ASPECT scoring process using validated machine-learning algorithms, leading to higher inter-reader agreement rates and more consistent evaluations of early ischemic changes.
Rapid ASPECTS is FDA-cleared as a CADx (computer-assisted diagnostic software) device, indicating it assists physician evaluation rather than replacing it. The system is designed and validated in compliance with 21 CFR, Part 820.30 requirements, and RapidAI maintains HIPAA, GDPR, ISO 13485, ISO 27001, and ISO 27701 certifications for secure data management.
Rapid ASPECTS is an adjunct tool intended to assist, not replace, a clinician's review of original imaging or their clinical judgment, and generated output should not be the primary interpretation without physician concurrence. It has been validated primarily for early brain ischemia (within 6 hours) in patients with known MCA or ICA occlusions, although recent updates may extend this. The underlying ASPECTS score itself also has inherent limitations, such as being primarily for anterior circulation.
Alternatives include manual ASPECT scoring by radiologists and neurologists, or other AI-based stroke imaging software solutions. Rapid ASPECTS differentiates itself by providing automated, standardized, and rapid ASPECT scores, which has been shown to improve accuracy and consistency, especially for less experienced readers, compared to manual interpretation. Other imaging modalities like CT perfusion or MRI also provide valuable information for stroke assessment.
The pricing for Rapid ASPECTS varies based on factors like geographical region, hospital type, and the specific modules purchased, with a single module starting around $12,000 in the US. RapidAI operates on an annual subscription model that includes updates, 24/7 support, and training. While specific reimbursement for Rapid ASPECTS should be verified, RapidAI products aim to provide cost and time savings, and some of their other modules have qualified for new technology add-on payments (NTAP).
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| Last Verified: 2026-04-18 | First Added: 2026-04-18