Products

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana
Cardiology AI
Anumana's FDA-cleared ECG-AI LEF 12-Lead algorithm uses artificial intelligence to detect low ejection fraction from routine 12-lead ECGs, aiding in the early identification of heart failure risk.
Low Ejection Fraction AI-ECG Algorithm
Anumana
Cardiology AI
Anumana's FDA-cleared ECG-AI LEF is a breakthrough artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure using a standard 12-lead electrocardiogram (ECG).

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About Anumana

Anumana is an AI-driven health technology company co-founded by nference and Mayo Clinic, dedicated to transforming cardiovascular care. Their core mission is to leverage cutting-edge artificial intelligence and translational science to decipher the electrical signals of the heart, enabling earlier and more accurate diagnosis, treatment, and interventions in cardiology.

The company develops and commercializes software-as-a-medical-device (SaMD) solutions, which include FDA-cleared ECG-AI algorithms. These algorithms analyze standard 10-second or 12-lead electrocardiograms (ECGs) to detect subtle patterns invisible to the human eye, revealing critical information about heart conditions. For instance, their FDA-cleared ECG-AI LEF (low ejection fraction) technology identifies reduced heart function, and they have the first and only FDA-cleared ECG-AI algorithm for cardiac amyloidosis using standard 12-lead ECGs. Anumana’s algorithms are built upon extensive proprietary datasets, including over 25 million longitudinal patient data from leading institutions and more than 100,000 paired ECGs and echocardiograms, ensuring high accuracy and representation across diverse patient populations.

Beyond diagnostics, Anumana is expanding its focus into perioperative cardiac care, developing novel generative AI imaging and visualization technologies, and real-time procedural support tools for structural heart, interventional cardiology, and electrophysiology procedures. Their solutions are designed to integrate seamlessly into existing clinical workflows, providing physicians with crucial, actionable insights at the point of care to improve patient outcomes throughout the entire cardiac care continuum.

Focus Areas

Cardiovascular AI ECG analysis early disease detection heart failure pulmonary hypertension cardiac amyloidosis electrophysiology perioperative cardiac care generative AI imaging clinical decision support software as a medical device (SaMD)

Business Intelligence

Key Investorsnference, Mayo Clinic Ventures, Matrix, Matrix Capital Management, NTT Venture Capital, Boston Scientific, MedTech Innovator
PartnershipsPfizer, Novartis Pharmaceuticals Corporation, Philips, AliveCor, American College of Cardiology (ACC)
AcquisitionsNeuCures (also referred to as NeuTrace)
TechnologyECG-AI Platform, multimodal generative AI platform, Software as a Medical Device (SaMD), nference's nSights real-world evidence generation platform, integrates with EHR systems and ECG platforms, cloud-native
FDA Clearances3 cleared products (estimated)

What Physicians Need to Know

Specialization: Cardiovascular AI Diagnostics
Anumana specializes in developing AI-driven software-as-a-medical-device (SaMD) solutions for early detection and improved diagnosis of various cardiovascular conditions using standard 12-lead electrocardiograms (ECGs). Their portfolio includes FDA-cleared algorithms for low ejection fraction (LEF) and pulmonary hypertension (PH), and algorithms with FDA Breakthrough Device Designation for hyperkalemia and cardiac amyloidosis.
Specialization: Perioperative & Acute Cardiac Care
Beyond diagnostics, Anumana is expanding into perioperative and acute cardiac care, developing novel generative AI imaging and visualization technologies. These aim to provide real-time imaging platforms and predictive algorithms for interventions in structural heart, interventional cardiology, and electrophysiology procedures.
Key Differentiator: Mayo Clinic & nference Foundation
Anumana was co-founded by Mayo Clinic and nference, leveraging Mayo Clinic's deep clinical expertise and extensive patient data with nference's advanced AI capabilities and translational science. This partnership provides a robust foundation for their AI algorithm development and clinical validation.
Key Differentiator: Extensive Data & Clinical Validation
Their AI algorithms are built on extensive proprietary datasets, including over 25 million longitudinal patient data from leading institutions and more than 100,000 paired ECGs and Echos. This is backed by rigorous clinical validation with over 75 peer-reviewed publications and multiple retrospective and prospective studies, demonstrating improved diagnostic accuracy.
Key Differentiator: Regulatory Achievements
Anumana has secured multiple FDA clearances for its ECG-AI algorithms, including for LEF and PH, and has received several FDA Breakthrough Device Designations for other algorithms, highlighting their commitment to developing regulated, clinically impactful medical devices.
Technology Stack: Deep Learning & Multimodal AI
Their core technology involves deep learning for ECG/EGM analysis, advanced electrocardiography (ECG) signal processing, and electrogram (EGM) analytics. They utilize multimodal AI systems that leverage nference's platform with deep longitudinal de-identified patient data.
Technology Stack: Workflow Integration & Real-time Insights
Anumana develops web-based clinical dashboards (zero-footprint) and low-latency real-time inference engines. Their solutions are designed for seamless integration into existing EHRs and ECG information management systems, providing real-time AI results and workflow tools.
Physician Tip

For physicians, Anumana's AI tools transform routine 12-lead ECGs into powerful diagnostic instruments, enabling earlier detection of hidden cardiovascular conditions like low ejection fraction, pulmonary hypertension, hyperkalemia, and cardiac amyloidosis. This can lead to more timely interventions, optimize the utilization of more expensive diagnostic tests like echocardiograms, and improve diagnostic confidence at the point of care. The integration into existing clinical workflows means minimal disruption, allowing for enhanced cardiac assessment and more appropriate referrals to specialists, ultimately improving patient outcomes and potentially preventing disease progression.

Anumana's platform is designed for seamless integration across diverse healthcare systems, including EHRs and ECG information management systems. They have established key partnerships, such as with Philips for their ECG AI Marketplace, making their FDA-cleared LEF algorithm available through Philips' ECG portfolio. Additionally, they are collaborating with InfoBionic.Ai to integrate their ECG-AI algorithms into remote cardiac telemetry platforms, expanding their reach to wearable lower-lead ECGs in patients' homes.

Products by Anumana

2 products in the directory

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana
Cardiology AI
Anumana's FDA-cleared ECG-AI LEF 12-Lead algorithm uses artificial intelligence to detect low ejection fraction from routine 12-lead ECGs, aiding in the early identification of heart failure risk.
Low Ejection Fraction AI-ECG Algorithm
Anumana
Cardiology AI
Anumana's FDA-cleared ECG-AI LEF is a breakthrough artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure using a standard 12-lead electrocardiogram (ECG).

What the Web Says

Anumana is an AI-driven health technology company that develops ECG algorithms for early disease diagnosis and intervention, with a focus on cardiovascular conditions. Their technology analyzes the heart's electrical signals to reveal insights beyond human detection capabilities, aiming to identify at-risk patients earlier and inform ongoing care. The company was founded in 2021 as a collaboration between the Mayo Clinic and nference. Anumana has received FDA clearance for its cardiac ECG-AI algorithm to detect low ejection fraction (LEF) and for its pulmonary hypertension algorithm, with a cardiac amyloidosis algorithm also receiving Breakthrough Device Designation.

Overall: Positive

Strengths

  • AI-driven ECG algorithms enable early disease diagnosis and intervention, particularly for cardiovascular conditions.
  • Technology is built on extensive patient records (over 22 million) and validated through numerous peer-reviewed publications.
  • Algorithms provide clinically validated insights and integrate seamlessly into existing clinical workflows without requiring new hardware.
  • Focus on proactive care, improving patient outcomes and potentially reducing healthcare costs.
  • Received FDA clearances and Breakthrough Device Designation for key algorithms.
  • Strong commitment to excellence in the development and manufacturing of regulated medical devices, as evidenced by ISO 13485 certification.

Limitations

  • Limited public reviews available on platforms like G2, Glassdoor, and Capterra specifically for Anumana, making it difficult to gauge widespread user satisfaction for their products or as an employer.
  • Some search results were for similarly named companies (e.g., Animana, Amana, Humana, Anaplan, Anomalo, Asana, Lumana, Yumana, uman.ai), which could lead to confusion when researching.

Based on reviews from: anumana Inc Average Salary, Pay Ranges & Benefits, Anumana - Jobs, Funding & Reviews - Employbl, Working at Humana: 8,280 Reviews | Indeed.com, Working as an IT at Humana: Employee Reviews | Indeed.com, Anumana - Unlocking the Language of the Heart, Animana Reviews 2026. Verified Reviews, Pros & Cons - Capterra, IT Operations & Helpdesk reviews at Humana in Remote | Indeed.com, Working at amana in Houston, TX: Employee Reviews | Indeed.com, Working as a Help Desk Analyst at Humana: Employee Reviews | Indeed.com, Amana - Reliable? : r/hvacadvice - Reddit, Anumana Makes Educated Inferences in Heart Failure, Cardiac Care AI Company, Anumana, Announces Receipt of ISO 13485 Certification | DAIC, Anumana: Interview With CEO Maulik Nanavaty About The AI-Driven Health Technology Company - Pulse 2.0, Working at amana: Employee Reviews | Indeed.com, Working as an Analyst at Humana: 70 Reviews | Indeed.com, Capterra Pros and Cons | User Likes & Dislikes - G2, Lumana Reviews 2026: Details, Pricing, & Features - G2, Capterra Reviews 2026: Details, Pricing, & Features | G2, Anaplan Reviews 2026: Details, Pricing, & Features | G2, Yumana Software Pricing, Alternatives & More 2026 - Capterra, Asana Software Pricing, Alternatives & More 2026 | Capterra, Asana Reviews 2025 - G2, Anomalo Reviews 2026: Details, Pricing, & Features - G2, uman.ai Reviews 2026: Details, Pricing, & Features - G2

Last updated: 2026-07-19

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Press & Coverage

Anumana Inc.
Anumana Receives First and Only FDA Clearance for ECG-AI Cardiac Amyloidosis Algorithm Using a Standard 12-Lead ECG
Anumana announced FDA clearance for its ECG-AI algorithm for cardiac amyloidosis, making it the first and only such algorithm cleared for this indication using standard 12-lead ECGs. This AI-enabled software-as-a-medical-device (SaMD) aims to help clinicians identify patients at risk for cardiac amyloidosis at the point of care.
2026-04
Anumana Inc.
Anumana Secures FDA Clearance for First-of-Its-Kind ECG-AI Algorithm for Early Detection of Pulmonary Hypertension
Anumana has received FDA 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled software-as-a-medical-device (SaMD) that detects early signs of PH. This is the first PH algorithm cleared for use with standard 12-lead ECGs, making it broadly accessible across care settings.
2026-03
Anumana Inc.
Anumana Named to Fast Company's 2026 Most Innovative Companies Awards
Anumana was named to Fast Company's 2026 Most Innovative Companies list in the Medical Devices category for its AI-enabled detection algorithms that uncover hidden cardiovascular disease from routine electrocardiograms.
2026-03
Anumana Inc.
Anumana Appoints Kevin Ballinger and Jean-Luc Butel to Board of Directors
Anumana Inc. announced the appointment of Kevin Ballinger and Jean-Luc Butel to its Board of Directors, bringing extensive experience in the healthcare and medical device industries.
2026-01
Anumana Inc.
Anumana Advances AI-Driven Cardiovascular Science with Late-Breaking Heart Failure Study and Multiple Abstracts at AHA 2025
Anumana presented new clinical data at the American Heart Association (AHA) Scientific Sessions 2025, including a late-breaking study showing that AI applied to ECGs can enhance near-term prediction of incident heart failure.
2025-11
Anumana Inc.
How Anumana AI Is Powering the First Certified Tool on Philips ECG AI Marketplace
Philips launched its ECG AI Marketplace with Anumana AI's FDA-cleared Low Ejection Fraction (LEF) algorithm as its first certified third-party tool, integrating advanced AI into cardiology workflows for earlier detection of hidden heart conditions.
2025-10
BioSpace
Anumana Expands AI Platform from Diagnostic Solutions to the Full Continuum of Cardiovascular Care
Anumana has expanded its AI platform beyond diagnostic ECG-AIu2122 technology into perioperative and acute cardiac care, fueled by a Series C financing round that included new investor Boston Scientific Corporation.
2025-04
MarketScreener
Anumana, Inc. announced that it has received funding from Boston Scientific Corporation, Matrix Capital Management, Mayo Clinic, Endowment Arm, Matrix Management Corporation, NTT Venture Capital
Anumana, Inc. received $95.399999 million in Series C funding from Boston Scientific Corporation, Matrix Capital Management, Mayo Clinic, Endowment Arm, Matrix Management Corporation, and NTT Venture Capital.
2025-04

Frequently Asked Questions

Anumana offers FDA-cleared ECG-AIu2122 algorithms as Software-as-a-Medical-Device (SaMD) for the early detection of conditions such as low ejection fraction (LEF), pulmonary hypertension (PH), and cardiac amyloidosis (CA) using standard 12-lead ECGs. The company is also developing generative imaging applications and real-time procedural support tools for perioperative cardiac care.
Anumana's ECG-AI algorithms have received multiple FDA clearances, including Breakthrough Device Designations and 510(k) clearances, demonstrating regulatory compliance. Their pulmonary hypertension algorithm, for example, integrates with EHR systems and operates within the health system environment without transferring patient data, enhancing data security. Anumana also maintains a Coordinated Vulnerability Disclosure policy to address product security.
Anumana's ECG-AI algorithms are designed to integrate directly with existing clinical workflows and EHR systems, including ECG management platforms. This allows clinicians to leverage AI-powered insights from routine 12-lead ECGs at the point of care, supporting earlier diagnosis and more timely next steps in patient management.
Anumana was co-founded by nference and Mayo Clinic, leveraging extensive clinical and technical expertise. They have strategic collaborations with companies like Pfizer, Novartis, Philips, and AliveCor. Their algorithms are rigorously validated in large, independent, multi-center studies across various U.S. health systems, often using hundreds of thousands of de-identified patient records.
Anumana, founded in 2021, demonstrates strong company stability with significant backing. They secured a Series C investment on April 24, 2025, with investors including Boston Scientific, Matrix Capital Management, Mayo Clinic Ventures, and NTT Venture Capital, having raised a total of $185M across multiple funding rounds. The company has between 101-200 employees.
While specific pricing models are not publicly disclosed, Anumana's FDA-cleared ECG-AIu2122 algorithms for low ejection fraction, pulmonary hypertension, and cardiac amyloidosis are currently available in the U.S. and are eligible for reimbursement. Healthcare providers should contact Anumana directly for detailed pricing information.
Anumana offers a dedicated support team available via email to assist with questions, troubleshooting, and guidance for their ECG-AIu2122 solutions. They also provide resources such as indications for use, instructions for use, publications, and educational content to maximize the value of their AI in clinical practice.

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