Products

prolaio eVO2peak Module
Prolaio
Cardiology AI
Prolaio is a clinical intelligence company that develops FDA-cleared software, such as the eVO2peak Module, to estimate peak oxygen consumption using real-world patient data for cardiovascular research and care.

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About Prolaio

Prolaio is a clinical intelligence company that leverages advanced data science and artificial intelligence to revolutionize cardiovascular care and research. The company’s platform integrates a connected system powered by real-world patient data, enabling personalized care plans and improved outcomes for individuals with heart conditions. Prolaio’s FDA-cleared software and proprietary algorithms are designed to collect continuous, high-density cardiovascular data from wearable biosensors, translating this information into actionable insights for clinicians and researchers.

For physicians, Prolaio’s technology offers a means to move beyond episodic data, providing a more comprehensive and continuous understanding of a patient’s heart health. This approach supports early intervention points, evidence-based care plans, and the proactive management of conditions like heart failure. The platform also plays a crucial role in clinical research and drug development by optimizing study design, increasing statistical power, and enhancing confidence through better data, ultimately aiming to accelerate therapeutic discovery and deliver precision cardiovascular care.

Founded by experts in cardiovascular medicine and data science, Prolaio is committed to addressing cardiovascular disease, the leading cause of death worldwide, by transforming real-world heart data into faster discovery and precision care. The company’s innovative approach focuses on patient-centered, science-driven solutions, utilizing digital biomarkers to predict physiological changes and empower more timely and effective interventions.

Focus Areas

Precision cardiology cardiovascular care clinical research real-world data advanced analytics AI patient monitoring drug development heart disease heart failure hypertrophic cardiomyopathy (HCM)

Business Intelligence

PartnershipsKardigan (acquisition), physIQ (acquisition by Prolaio)
AcquisitionsAcquired by Kardigan (March 27, 2025); Acquired physIQ
TechnologyCloud-native platform leveraging advanced data science, proprietary algorithms, and real-world patient data. Utilizes AWS, Amazon S3, and Amazon CloudFront. Focuses on digital biomarkers and continuous physiological data streams from wearable biosensors.
FDA Clearances5 cleared products (estimated)

What Physicians Need to Know

Precision Cardiology & Cardiovascular Care
Prolaio is dedicated to revolutionizing cardiovascular care by integrating a connected platform powered by advanced data science, enabling personalized care and improved patient outcomes. They focus on proactive and continuous patient management, extending beyond traditional episodic clinic visits.
Real-World Data & Advanced Analytics/AI
A core differentiator, Prolaio unlocks access to continuous, predictive, and shareable high-density heart data. They leverage cutting-edge analytics and machine learning algorithms to identify high-risk individuals, predict potential complications, and personalize treatment plans. Their platform includes FDA-cleared software and proprietary algorithms, built upon one of the industry's largest curated cardiovascular data sets.
Clinical Research Acceleration
Prolaio significantly accelerates clinical research by facilitating eligible patient identification, providing deep, high-density data insights, and reducing variability. Their technology-enabled platform optimizes study design, decreases overhead, and enhances confidence in trial results, ultimately transforming the pace of drug development and patient outcomes.
Comprehensive Patient Monitoring
They offer improved, near real-time monitoring through wearable devices and remote systems that track vital signs like heart rate and rhythm. Their comprehensive kit for patients includes a wrist monitor, smart blood pressure cuff, smart scale, a pre-loaded phone with their app, and ECG patches, providing 24/7 connected heart care.
Drug Development Support
Prolaio's platform and extensive data sets are instrumental in modernizing cardiovascular drug development. By integrating high-density patient data and advanced analytics, they help partners design better trials, discover more targeted medicines, and accelerate the development of novel therapies.
Specialization in Heart Failure & HCM
Prolaio provides targeted solutions for heart failure, including Hospital-to-Home Transition Care with continuous monitoring and risk assessment. They are pioneers in managing Hypertrophic Cardiomyopathy (HCM) with technology, enabling early detection, personalized care, and aiming to make the disease more predictable and systematic.
Key Differentiators
Prolaio stands out due to its focus on high-density, continuous real-world heart data, FDA-cleared software with proprietary AI algorithms, and its ability to unite patients, providers, and researchers on a single intuitive platform. Their pioneering work in AI-based analytics and extensive curated cardiovascular data sets, coupled with ISO 13485:2016 and MDSAP certifications, underscore their commitment to quality and innovation.
Technology Stack
Their technology stack includes wearable devices (wrist monitors, smart BP cuffs, smart scales, ECG patches/biosensors), a proprietary mobile application for patient engagement, telemedicine platforms for enhanced communication, advanced analytics and machine learning algorithms for predictive insights, and a secure, cloud-based 'Prolaio Monitoring Workbench' for clinicians.
Physician Tip

For physicians, Prolaio offers unparalleled data-driven insights, enabling more informed clinical decisions and the ability to personalize treatment plans based on continuous, real-world patient data. The platform facilitates early detection and timely intervention, potentially reducing hospitalizations and emergency visits, especially for conditions like heart failure and HCM. Its FDA-cleared and rigorously validated technology builds trust, while the integrated approach simplifies workflows and enhances patient engagement through remote monitoring and communication tools. This allows for a more proactive and effective management of cardiovascular conditions.

Prolaio's platform is designed to integrate high-density patient data and proprietary algorithms to deliver outcome-driven insights. While specific third-party integrations are not explicitly detailed beyond their own comprehensive kit, their acquisition by Kardigan indicates a strategic integration into drug development pipelines. Their platform is built to unite patients, providers, and researchers, suggesting a capability for data sharing and collaboration within the healthcare ecosystem.

Products by Prolaio

1 product in the directory

prolaio eVO2peak Module
Prolaio
Cardiology AI
Prolaio is a clinical intelligence company that develops FDA-cleared software, such as the eVO2peak Module, to estimate peak oxygen consumption using real-world patient data for cardiovascular research and care.

What the Web Says

Prolaio is a clinical intelligence company focused on cardiovascular health, utilizing data-driven technology and FDA-cleared algorithms for remote patient monitoring, clinical research, and drug development. The company emphasizes a pioneering and collaborative culture, with employees reporting high satisfaction due to a shared mission and supportive environment. Prolaio was recently acquired by Kardigan, which is seen as an opportunity to amplify its impact in cardiovascular care.

Overall: Positive

Strengths

  • Pioneering and innovative company culture focused on cardiovascular care.
  • Collaborative and supportive work environment with responsive colleagues.
  • Meaningful work that aims to improve patient outcomes and advance clinical goals.
  • Strong focus on scientific rigor and building FDA-cleared, clinically credible technology.
  • Offers competitive compensation, comprehensive health benefits, and flexible/hybrid work options.
  • User-centered design approach for product development, leading to effective tools.

Limitations

  • No specific product or employer cons were found across the searched platforms for Prolaio.
  • Some general concerns about privacy are sometimes raised with proctoring software, but this is not specific to Prolaio.
  • One review for a different company with a similar name mentioned inconsistent work and low pay, but this is not Prolaio.

Based on reviews from: Built In, G2, Capterra, ZipRecruiter, Indeed.com, SimplyHired

Last updated: 2026-07-19

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Press & Coverage

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 to establish a leading heart health company, integrating Prolaio's cardiovascular data and analytics platform to accelerate drug development and improve patient care. 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, a move expected to accelerate the impact of its software and bring more effective cardiovascular treatments to patients globally. The combination aims to revolutionize cardiovascular care and clinical research through real-world patient data and advanced analytics.
2025-03
Fierce Biotech
Kardigan weaves health tech firm Prolaio into cardio R&D fabric - Fierce Biotech
Kardigan's acquisition of Prolaio integrates a new digital data platform into its R&D, providing access to Prolaio's extensive cardiovascular data set and health monitoring technology. This union aims to reduce the time and cost of developing new cardiovascular medicines.
2025-03
Prolaio
How Prolaio Is Transforming Heart Health With Real-World Data and Clinical Intelligence
Prolaio's CEO discusses the company's evolution from its founding in 2022, highlighting its FDA-cleared, data-driven technology that uses continuous, real-world heart data to improve cardiovascular research and patient outcomes. The company's focus has expanded to power smarter clinical trials and drug development in partnership with companies like Kardigan.
2025-12
Prolaio
Prolaio's ISO 13485 Certificationu2014and Why It Matters in a Rapidly Evolving Regulatory Landscape
Prolaio has achieved ISO 13485:2016 and MDSAP certification, demonstrating its commitment to a quality-first approach in the design, manufacturing, and support of its medical devices. This certification strengthens collaboration, patient trust, and future innovation.
2025-07
Tracxn
Prolaio - 2026 Funding Rounds & List of Investors - Tracxn
Prolaio has raised a total of $25.5 million from one Series B funding round on July 26, 2023.
2026-06
accessdata.fda.gov
510(k) Premarket Notification - FDA
The FDA reviewed Prolaio's 510(k) premarket notification for its eVO2peak Module (Version 1.0), an all-software medical device intended for estimating peak oxygen consumption in adult patients. The device was determined to be substantially equivalent to legally marketed predicate devices.
2025-12
Circulation (American Heart Association)
Abstract 4138176: Identifying Clinical Stability After Heart Failure Discharge: A machine learning-based decision aid based on continuous ECG and accelerometry | Circulation
A study published in Circulation details the use of the Prolaio system in LINK-HF clinical trials to continuously record physiological parameters using a wearable device. Machine learning was employed to build predictive models for near-term risk of emergency room use, hospitalization, or death in heart failure patients.
2024-11

Frequently Asked Questions

Prolaio offers an FDA-cleared remote monitoring platform that captures continuous, high-density cardiovascular data. This platform includes a kit with devices like a wrist monitor, smart blood pressure cuff, smart scale, a pre-loaded phone with their app, and ECG patches, designed for proactive care and personalized insights. They also provide an FDA-cleared eVO2peak Module for estimating peak oxygen consumption.
Prolaio utilizes real-world heart data, advanced analytics, and proprietary AI algorithms to provide outcome-driven insights for cardiovascular research and drug development. Their platform helps accelerate clinical trials by optimizing study design, identifying eligible patients, reducing overhead, and increasing statistical power through high-density data insights. This approach aims to transform real-world data into faster therapeutic discovery and precision cardiovascular care.
Prolaio offers specialized solutions for Hospital-to-Home Transition Care for heart failure patients and continuous monitoring for Hypertrophic Cardiomyopathy (HCM). For HCM, their program provides a wearable monitoring solution with devices and a mobile app to track symptoms and analyze data for predictive insights. This enables care teams to proactively manage patient status and intervene if increasing risks are detected.
Prolaio's software is FDA-cleared, and the company is compliant with 21CFR Part 11 for electronic records and signatures. They are also ISO 13485:2016 certified for medical device quality management systems and MDSAP certified, ensuring rigorous quality and global standards. Prolaio employs reasonable and appropriate steps to protect personal information from unauthorized access, use, disclosure, alteration, and destruction, with data fully stored and processed in the United States.
Prolaio was acquired by Kardigan, a cardiovascular drug development company, in March 2025, but continues to function independently as a clinical intelligence company. This acquisition integrates Prolaio's data collection and analytics platform into Kardigan's R&D, enhancing drug development and expanding Prolaio's reach to more patients and providers. The partnership provides long-term stability and leverages Kardigan's operational scale and resources to accelerate cardiovascular innovation.
Prolaio offers a 'free-to-patients' wearable monitoring solution for conditions like HCM, aiming to make care accessible. For clinical intelligence and research services, their platform helps reduce overall trial costs and administrative overhead, though specific pricing details for healthcare organizations are not publicly disclosed. Prolaio provides 'always-on support' for patients and technical support for study participants, and their platform is designed to simplify workflows for care teams.
While direct EHR integration capabilities are not explicitly detailed, Prolaio's FDA-cleared software delivers outcome-driven insights to empower care teams and aims to simplify research workflows. The platform provides scheduled reports and a 'Monitoring Workbench' for care teams to track patient data, suggesting a system designed to integrate with existing clinical practices and inform treatment decisions. The company's focus on 'uniting patients, providers, and researchers on a single, intuitive platform' implies a design for seamless incorporation into healthcare ecosystems.

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