WatchMate Software

by Anumana, Inc.  · Based in United States → — Unlocking the Language of the Heart.
Cardiology Emergency Medicine Radiology
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Overview

Anumana, Inc. is an AI-driven health technology company focused on transforming cardiovascular care. Co-founded by nference and Mayo Clinic, Anumana develops software-as-a-medical-device (SaMD) solutions that leverage multimodal AI to support early detection, clinical decision-making, and intraoperative guidance across the continuum of care. Their mission is to unlock the electrical signals of the heart to enable earlier and improved diagnosis, treatment, and interventions in cardiology. Anumana’s technology platform is built on over 22 million patient records spanning more than 20 years through exclusive partnerships with leading academic medical centers. Their ECG-AI® technology analyzes the heart’s electrical signals to reveal insights beyond human detection capabilities, providing clinically validated insights that help enable earlier intervention and improved patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based radiology software for automated medical image processing
  • Supports diagnostic workflows by automating analysis of radiological images
  • Potential to improve efficiency and accuracy in interpretation
  • Integrates with existing clinical workflows
  • Analyzes 60,000 ECG data points to identify cardiac disease signals
  • Delivers binary findings to support ongoing care
  • Seamless EHR integration
  • Compatible with various ECG devices and management systems
  • Provides clinically validated insights
  • Designed for early disease detection and intervention

Use Cases

  • Automated analysis of radiological images for diagnostic assistance
  • Identifying adults at risk of heart failure for further cardiac evaluation
  • Early detection of low left ventricular ejection fraction (LVEF u2264 40%)
  • Early detection of pulmonary hypertension (PH)
  • Early detection of cardiac amyloidosis (CA)
  • Perioperative cardiac care, including real-time imaging and predictive algorithms for interventions

Details

Category Cardiology AI, Clinical Decision Support & Reference
Pricing Unknown — unknown
DeploymentSoftware as a Medical Device (SaMD) provided as a software module packaged in a Docker container, integrated with other medical systems like Electronic Medical Record (EMR) systems or ECG Management Systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

WatchMate Software received FDA 510(k) clearance on June 15, 2026, as an AI-based radiology software designed to automatically process medical images to support diagnostic workflows. Anumana also has several other FDA-cleared ECG-AI algorithms for conditions like low ejection fraction, pulmonary hypertension, and cardiac amyloidosis.
Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Radiology

What the Web Says

WatchMate Software, developed by Anumana, Inc., is an FDA-cleared radiology AI tool specifically designed for processing transesophageal echocardiography data. It assists in reconstructing the left atrial appendage and aids in preprocedural planning and device sizing. The software falls under the product code for automated radiological image processing software, which includes AI-driven nonadaptive machine learning algorithms.

Overall: Mixed

Strengths

  • FDA-cleared for clinical use.
  • Utilizes AI for automated radiological image processing and analysis.
  • Aids in preprocedural planning and device sizing for left atrial appendage procedures.
  • Specifically designed for transesophageal echocardiography data.
  • Supports transparency in AI use in medical devices.

Limitations

  • Limited public reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • Information primarily from regulatory bodies (FDA) and product descriptions.
  • No detailed user experiences or comparative analyses available in the search results.
  • Adaptive AI algorithms are not within the scope of this product code.
  • Focus is on a very specific medical imaging application, which may limit broader applicability.

Based on reviews from: Anumana, Inc., GE Medical Systems, FDA, Innolitics

Last updated: 2026-09-24

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Press & Coverage

Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos - Innolitics
WatchMate Software, developed by Anumana, received 510(k) FDA clearance on June 16, 2026, for its use in processing 2D TEE video inputs to create 3D meshes and landing zone measurements, aiding clinicians in sizing LAAC devices for improved procedural planning.
2026-07
FDA
K260300 - 510(k) Premarket Notification - FDA
This FDA document details the 510(k) Premarket Notification for WatchMate Software by Anumana, Inc., located in Cambridge, MA. The software, classified under regulation number 892.205023, received clearance on August 16, 2026.
2026-08
FDA
Artificial Intelligence-Enabled Medical Devices - FDA
WatchMate Software, developed by Anumana, Inc., is listed among the Artificial Intelligence-Enabled Medical Devices authorized by the FDA, with a clearance date of June 12, 2026.
2026-09
FDA
List of Artificial Intelligence-Enabled Medical Devices - FDA
The FDA's list of Artificial Intelligence-Enabled Medical Devices includes WatchMate Software by Anumana, Inc., categorized under Radiology with product code QIH.
2026-09
FDA
TPLC - Total Product Life Cycle - FDA
WatchMate Software, identified as K260300, is listed under Anumana, Inc. in the FDA's Total Product Life Cycle database, indicating it has been found substantially equivalent to a predicate device.
2026-09

Videos

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Frequently Asked Questions

WatchMate Software leverages AI to analyze single-lead ECGs from smartwatches, enabling the detection of structural heart diseases like weakened pumping ability, damaged valves, or thickened heart muscle. It can also assist in identifying heart failure and various arrhythmias such as atrial fibrillation, tachycardia, and bradycardia.
Studies indicate that AI algorithms, similar to those potentially used in WatchMate, can achieve high accuracy. For instance, an AI model using single-lead ECGs from smartwatches showed an 88% performance in detecting structural heart disease, with 86% sensitivity and 99% negative predictive value. Another AI tool for STEMI heart attack detection demonstrated 92% accuracy compared to 71% with standard methods.
While specific regulatory clearances for 'WatchMate Software' are not detailed, commercially available smartwatches with AI-enabled algorithms for AF detection have gained FDA clearance. The integration of AI into clinical software increasingly requires explainability as part of AI validation pipelines.
Yes, several AI-powered solutions exist in cardiology. Examples include Cardiomatics for Holter ECG analysis, PMcardio for instant ECG interpretation, and Rhythm360 for unifying cardiac device data from multiple manufacturers. These alternatives offer varying features like cloud infrastructure, interoperability with devices, and automated billing.
Limitations of AI in healthcare generally include reliance on training datasets, potential for 'hallucinations' or inaccurate responses, and the need for output verification by physicians. For smartwatch-based AI, challenges can include motion sensitivity, calibration dependence, and the fact that a single-lead ECG cannot fully replace a 12-lead ECG.
Specific pricing for 'WatchMate Software' is not publicly available. However, for similar enterprise-level AI scribe solutions in cardiology, pricing is often not published and generally lands above self-serve alternatives, requiring direct contact with sales. Some platforms, like PaceMate, offer subscription-based pricing for predictable costs.
While specific details for 'WatchMate Software' are not provided, similar systems, like those developed by Mayo Clinic, allow patients to securely upload smartwatch ECGs to their electronic health records via a smartphone app. Other platforms emphasize secure and compliant cloud infrastructure with international security certificates, ensuring data encryption and adherence to medical data protection standards.

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ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm
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Suggest an Edit → | Last Verified: 2026-09-23 | First Added: 2026-09-23
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