prolaio eVO2peak Module
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Regulatory Status Disclosed
Overview
The Prolaio eVO2peak Module is a software-only medical device (SaMD) designed to estimate peak oxygen consumption (eVO2peak) in adult patients. This module is intended for use by qualified clinicians as an adjunctive aid in the clinical evaluation of patients for whom cardiopulmonary functional testing is desired.
- What it does: The eVO2peak Module processes demographic data, single-lead ECG data (sampled at ≥125 Hz), and triaxial accelerometry data (sampled at ≥50 Hz) collected from third-party, FDA-cleared wearable sensors during a patient’s activities of daily living. It utilizes a deep-learning model, trained against reference Cardiopulmonary Exercise Test (CPET) data, to generate an eVO2peak estimate.
- Who it is for: It is intended for adult patients and clinicians who require an estimation of peak oxygen consumption. This can be relevant in cardiology and other specialties where cardiopulmonary functional capacity assessment is beneficial.
- How it fits a clinical or practice workflow: The module functions as a software library, integrating its outputs into external clinical systems rather than providing a direct user interface or display. This allows clinicians to incorporate the eVO2peak estimate into their overall patient evaluation alongside other standard clinical findings. Prolaio’s broader platform also supports continuous monitoring for patients transitioning from hospital to home after cardiac procedures or acute heart failure, and for managing hypertrophic cardiomyopathy (HCM), utilizing a mobile app and connected devices like ECG patches, blood pressure cuffs, and scales.
- Notable capabilities: The primary capability is providing an estimated VO2peak without requiring a formal CPET, using data collected during routine daily activities. This offers a less burdensome method for assessing cardiopulmonary functional capacity.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Estimates peak oxygen consumption (eVO2peak)
- Utilizes demographic data, single-lead ECG, and triaxial accelerometry inputs
- Processes data from qualified third-party FDA-cleared wearable medical sensors
- Applies a locked deep-learning model for eVO2peak estimation
- Provides information as an adjunctive aid in clinical evaluation
- Enables high-density, longitudinal data collection
- Leverages real-world patient data and insights
- Features FDA-cleared software and proprietary algorithms
- Offers remote patient monitoring capabilities
- Supports clinical trial enrichment and optimization
Use Cases
- Estimating eVO2peak for cardiopulmonary functional testing
- Adjunctive aid in the clinical evaluation of cardiovascular patients
- Advancing cardiovascular research and drug development
- Supporting Hospital-to-Home Transition Care for cardiac patients
- Monitoring progression of Hypertrophic Cardiomyopathy (HCM)
- Enhancing patient engagement and self-management of heart conditions
What Physicians Need to Know
ECG/EKG Analysis Capability
The prolaio eVO2peak Module utilizes single-lead ECG data as an input, alongside triaxial accelerometry and demographic data, to estimate peak oxygen consumption (eVO2peak). Its primary function is not comprehensive diagnostic ECG/EKG analysis for rhythm or morphology, but rather to process physiological data relevant to VO2peak estimation.
Arrhythmia Detection Accuracy
While the module processes single-lead ECG data, its stated purpose is the estimation of eVO2peak, not the detection or diagnosis of arrhythmias.
Heart Failure Risk Prediction
The module provides an estimated peak oxygen consumption (eVO2peak), which serves as an 'Adjunctive Cardiovascular Status Indicator.' VO2peak is a well-established metric for assessing cardiorespiratory fitness and is prognostically significant in conditions like heart failure, aiding clinicians in the overall evaluation of patients.
Cardiac Monitoring Integration
The prolaio eVO2peak Module integrates with qualified third-party FDA-cleared wearable medical sensors to collect necessary input data, including single-lead ECG and triaxial accelerometry, during patients' activities of daily living.
Real-Time Alert Capability
The module processes stored physiological data to return a mean eVO2peak and contextual information, indicating it is designed for retrospective analysis and adjunctive clinical evaluation rather than real-time alert generation.
Physician Tip
The prolaio eVO2peak Module is a valuable adjunctive tool for estimating cardiorespiratory fitness (eVO2peak) in adult patients, particularly when a full cardiopulmonary exercise test (CPET) is not feasible or desired. Utilize the eVO2peak results in conjunction with other clinical findings to assess cardiovascular status and guide patient management. It provides meaningful longitudinal data from daily living, offering insights into functional capacity. Remember that it relies on data from third-party wearable sensors, so ensure the use of qualified, FDA-cleared devices for data input.
The prolaio eVO2peak Module is a software-only medical device that requires input from qualified third-party FDA-cleared wearable medical sensors. These sensors must be capable of collecting single-lead electrocardiogram (at least 125 Hz) and triaxial accelerometry data (at 50 Hz) during activities of daily living. This highlights the necessity of a robust and compatible wearable ecosystem for effective utilization of the module.
Details
| Category | Cardiology AI, Clinical Decision Support & Reference |
| Pricing | Contact for pricing |
| Deployment | Cloud-based (software-only, processes remote sensor data) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The prolaio eVO2peak Module (Version 1.0) is an all-software medical device (Class II SaMD) intended for estimating peak oxygen consumption (eVO2peak (mL/kg/min)) in adult patients. It uses demographic data, single-lead electrocardiogram, and triaxial accelerometry data from qualified third-party FDA-cleared wearable medical sensors as inputs. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Physical Medicine & Rehab, Sports Medicine |
What the Web Says
The Prolaio eVO2peak Module is an all-software medical device designed to estimate peak oxygen consumption (eVO2peak) in adult patients. It uses demographic data, single-lead electrocardiogram, and triaxial accelerometry data from qualified third-party FDA-cleared wearable medical sensors. The module is intended as an adjunctive aid for qualified clinicians in the clinical evaluation of patients, not as a standalone diagnostic or for active patient monitoring.
Overall: PositiveStrengths
- Meets target accuracy, reliability, and bias criteria.
- Substantially equivalent to predicate devices, raising no new safety or effectiveness concerns.
- Utilizes real-world data from wearable sensors.
- Aids clinicians in evaluating patients.
- Part of a platform focused on improving heart health through continuous learning and collaboration.
Limitations
- Not intended for use as a diagnostic tool.
- Not for active patient monitoring.
- Should not be solely relied upon for determining patient status.
- Not an alarm device.
- Requires qualified third-party FDA-cleared wearable medical sensors as input.
Based on reviews from: accessdata.fda.gov, Indeed.com, How Prolaio Is Transforming Heart Health With Real-World Data and Clinical Intelligence
Last updated: 2026-07-18
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Press & Coverage
Innolitics
prolaio eVO2peak Module (Version 1.0) (K252204) u2014 FDA 510(k)
The prolaio eVO2peak Module (Version 1.0), an all-software medical device, received FDA 510(k) clearance on December 16, 2025, for estimating peak oxygen consumption (eVO2peak) in adult patients as an adjunctive aid in clinical evaluation. It processes demographic data, single-lead ECG, and triaxial accelerometry from FDA-cleared wearable sensors.
2025-12
accessdata.fda.gov
December 16, 2025 prolaio, Inc. George Allen Hides Vice President, Regulatory, Quality, and Clinical 230 W Monroe, Unit 2560 Chi - accessdata.fda.gov
This FDA document details the 510(k) premarket notification for the prolaio eVO2peak Module (Version 1.0), an all-software medical device intended to estimate peak oxygen consumption in adult patients. The clearance was granted on December 16, 2025, classifying it as an Adjunctive Cardiovascular Status Indicator.
2025-12
BioSpace
Kardigan Acquires Prolaio to Create a Pioneering Heart Health Company with One-of-a-Kind Integrated Cardiovascular Data and Therapeutics Platform
Kardigan acquired Prolaio on November 6, 2025, to create a comprehensive heart health company, integrating Prolaio's clinical intelligence platform and extensive cardiovascular data with Kardigan's drug development capabilities. Prolaio will continue to operate independently, providing real-world driven insights and services.
2025-11
Prolaio
Prolaio and Kardigan Combination: A New Era of Heart Health Innovation
Prolaio announced its acquisition by Kardigan on March 27, 2025, aiming to accelerate cardiovascular care and clinical research through advanced analytics and real-world patient data. This combination is expected to enhance Kardigan's drug development pipeline and expand Prolaio's reach in providing cutting-edge insights.
2025-03
Prolaio
How Prolaio Is Transforming Heart Health With Real-World Data and Clinical Intelligence
Published on December 18, 2025, this article discusses Prolaio's evolution since its 2022 inception and its acquisition by Kardigan, highlighting its FDA-cleared, data-driven technology that uses continuous, real-world heart data to improve cardiovascular research and patient outcomes. The company aims to prevent avoidable heart events and discover targeted medicines.
2025-12
Business Wire
Kardigan Announces Multiple Presentations at ACC.26 from its Late-Stage Portfolio of Personalized Cardiovascular Medicines
On March 17, 2026, Kardigan announced multiple presentations at ACC.26, including two posters from its subsidiary Prolaio's LINK-HF2 trial, which will highlight the clinical value of continuous ECG/activity monitoring in identifying changes in heart failure risk. These presentations underscore the depth of Kardigan's pipeline and commitment to advancing cardiovascular care.
2026-03
BEUDAMED
prolaio eVO2peak Module (Version 1.0) - BEUDAMED
This entry confirms the FDA 510(k) clearance for the prolaio eVO2peak Module (Version 1.0) on December 16, 2025, classifying it as a Class 2 medical device under regulation number 870.2200.
2025-12
510k Monitor
PPW u2014 Adjunctive Cardiovascular Status Indicator: clearances, recalls, review times - 510k Monitor
The 510k Monitor lists the prolaio eVO2peak Module (Version 1.0) as a recent clearance under the FDA product code PPW (Adjunctive Cardiovascular Status Indicator) on December 16, 2025. This indicates its classification as a Class II prescription device intended for adjunctive use with other patient information.
2025-12
Videos
Product demos, reviews, and walkthroughs for prolaio eVO2peak Module.
Heart Surgeon BEGS You: STOP Sleeping This Way u2014 It Could Trigger a Stroke Overnight | Senior Health
Frequently Asked Questions
The prolaio eVO2peak Module is an all-software medical device that employs a locked deep-learning model to estimate peak oxygen consumption (eVO2peak) using demographic data, single-lead ECG, and accelerometry from wearable sensors. It serves as an adjunctive aid for qualified clinicians in the evaluation of adult patients, rather than a standalone diagnostic tool or for active patient monitoring.
The prolaio eVO2peak Module is an FDA-cleared Class II Software as a Medical Device (SaMD) and adheres to FDA's Good Machine Learning Practice (GMLP) principles. Prolaio also maintains compliance with 21 CFR Part 11 for electronic records, ISO 13485:2016 for medical device quality management systems, and is MDSAP certified, ensuring robust data integrity, privacy, and cybersecurity.
The prolaio eVO2peak Module has demonstrated target accuracy, reliability, and bias criteria in clinical validation studies across a diverse adult patient population. However, it is not intended for use as a diagnostic, for active patient monitoring, or as the sole basis for determining patient status. The module requires inputs from qualified third-party FDA-cleared wearable medical sensors.
Prolaio is committed to safeguarding data integrity, privacy, and cybersecurity through a risk-based quality management system. The eVO2peak Module incorporates encryption, access control, input validation, and logging within its secure product development framework, with all cybersecurity risks evaluated as acceptable. Furthermore, all patient personal information is stored and processed exclusively within the United States.
While the search results highlight Prolaio's broader platform for connecting patients, care teams, and researchers to enable proactive care and clinical insights, specific details regarding direct EHR integration for the eVO2peak module are not explicitly provided. The module's design and human factors engineering aim to ensure safe integration and interpretation of outputs by clinical users within existing workflows.
The established gold standard for directly measuring VO2peak is cardiopulmonary exercise testing (CPET) performed in a clinical setting. While other remote cardiac monitoring solutions like patch monitors and mobile cardiac telemetry exist for general cardiac rhythm surveillance, they are not presented as direct alternatives for AI-driven *estimation* of VO2peak.
Specific pricing models for the prolaio eVO2peak Module are not publicly disclosed in the available information, which is common for specialized medical device software. The cost-effectiveness of such a module would typically be assessed based on factors like improved patient risk stratification, potential reduction in the need for more invasive or resource-intensive diagnostic procedures, and enhanced clinical decision support.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19