physIQ Heart Rhythm and Respiratory Module

by physIQ  · Based in United States →The leader in digital medicine, dedicated to generating unprecedented health insight using continuous wearable biosensor data and advanced analytics.
Cardiology Critical Care Pulmonology

Contact for pricing
Regulatory Status Disclosed

Overview

physIQ is an advanced artificial intelligence software solution focused on delivering real-time, data-driven insights for healthcare applications. It is an AI-based personalized physiology data analytics platform designed to continuously track vital signs and detect clinically relevant changes against a personal baseline, rather than population-based norms. The platform is cloud-based and continuously collects and processes data from any wearable biosensor using a deep portfolio of FDA-cleared analytics and digital biomarkers. It is intended to enhance virtual care models through the collection of near real-time physiologic vital signs, contextual insights, and personalized patented analytics. The physIQ solution is a single platform for virtual care models such as post-acute remote patient monitoring/management, and Hospital-at-Home programs. It makes it possible to monitor, analyze, detect, and predict patient decompensation/complications across a wide range of disease states. The platform includes patient tools (wearable device/phone app for vital sign data and ePROMs), analytics (FDA-cleared cloud-based AI), and clinician tools (patient management dashboard to notify clinicians of early patient decompensation). physIQ’s technology is an early warning platform and not a diagnostic tool.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based personalized physiology analytics
  • Continuous wearable biosensor data collection
  • FDA-cleared analytics and digital biomarkers
  • Learns individual patient baseline
  • Detects subtle physiological changes and early signs of decompensation
  • Calculates heart rate and heart rate variability
  • Detects atrial fibrillation
  • Determines respiration rate
  • Patient tools (wearable device / phone app) and ePROMs
  • Clinician management dashboard for notifications

Use Cases

  • Remote patient monitoring (RPM)
  • Post-acute care management
  • Hospital-at-Home programs
  • Clinical trial support (e.g., pharmacovigilance, efficacy tracking)
  • Early detection of heart failure exacerbations
  • Monitoring high-risk COVID-19 patients

What Physicians Need to Know

ECG/EKG Analysis Capability
Analyzes single-lead ECG signals to calculate heart rate, heart rate variability, and detect atrial fibrillation. It processes data from FDA-cleared ECG biosensor devices.
Arrhythmia Detection Accuracy
Includes FDA 510(k) cleared analytics for atrial fibrillation (AFib) detection, as well as a Heartbeat Detector algorithm.
Heart Failure Risk Prediction
physIQ's AI platform can predict impending heart failure exacerbations requiring hospitalization or emergency department visits with a mean of 10.4 days warning, demonstrating sensitivity up to 88% and specificity of 86%. This is achieved by establishing personalized physiological baselines and detecting subtle deviations in heart rate, rhythm, respiration, and activity.
Cardiac Monitoring Integration
Designed for integration into end-to-end systems by customer organizations, supporting data collection from FDA-cleared ECG biosensors using 'wet' electrode technology and triaxial accelerometers. The pinpointIQ platform is device-agnostic and can capture continuous multivariate physiological data from various wearable sensors.
AHA/ACC Guideline Alignment
The physIQ platform and its analytics are FDA-cleared, indicating clinical validation. A breakthrough study validating the technology's ability to detect heart failure exacerbation was published in Circulation u2013 Heart Failure, a journal of the American Heart Association.
Real-Time Alert Capability
Features a patient management dashboard that notifies clinicians of early patient decompensation, enabling prompt intervention. The analytics detect subtle physiological changes that may precede disease exacerbation or changes in health.
Physician Tip

Leverage the physIQ Heart Rhythm and Respiratory Module for continuous, remote monitoring of adult patients in subacute clinical and non-clinical settings. Focus on its FDA-cleared capabilities for atrial fibrillation detection, heart rate variability analysis, and particularly its proven ability to predict heart failure exacerbations days in advance. Integrate the personalized physiological analytics into existing workflows to enable proactive interventions and potentially reduce hospital readmissions. Remember that the module is not intended for life-supporting or life-sustaining systems or as ECG/respiration alarm devices.

The physIQ Heart Rhythm and Respiratory Module is designed to be integrated into a customer's existing end-to-end monitoring system. It is compatible with FDA-cleared, chest-worn biosensors utilizing 'wet electrode' technology that capture single-lead digital ECG data and triaxial accelerometer data. The platform is device-agnostic, allowing flexibility in sensor choice, and has demonstrated integration with devices like the Omron HeartGuide for comprehensive physiological data capture. The collected raw telemetry is uploaded to a cloud-based platform for analysis by FDA-cleared AI analytics.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentCloud-based platform
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The physIQ Heart Rhythm and Respiratory Module (K183322) received FDA 510(k) clearance on July 10, 2019, as a Class II device (21 CFR 870.2340, Product Code DPS). It is a computerized all-software callable function library in Python designed for calculating heart rate, heart rate variability, detecting atrial fibrillation, and determining respiration rate using ambulatory ECG and triaxial accelerometer data. It is intended for use by physicians or other qualified medical professionals in adult patients in subacute clinical and non-clinical settings for remote patient monitoring, but not for life-supporting or life-sustaining systems or as ECG or respiration alarm devices. Given its function and FDA clearance for handling patient physiological data, physIQ's operations inherently require adherence to HIPAA regulations and the execution of Business Associate Agreements (BAAs).

Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Pulmonology

What the Web Says

The physIQ Heart Rhythm and Respiratory Module is an FDA-cleared software device that utilizes AI-based personalized physiology analytics to continuously monitor heart rate, heart rate variability, atrial fibrillation, and respiration rate from wearable biosensors. It aims to detect subtle physiological changes and early signs of cardiac or respiratory decompensation, providing proactive insights for long-term patient management and early intervention, particularly in subacute clinical and nonclinical settings. The platform is designed to integrate with existing customer systems via API or middleware scripts.

Overall: Positive

Strengths

  • Continuous, long-term, and passive monitoring of patients using wearable biosensors.
  • Excels at establishing personalized physiological baselines.
  • Leverages FDA-cleared AI analytics to detect subtle, early signs of cardiac or respiratory decompensation.
  • Provides proactive, predictive insights for long-term patient management and early intervention.
  • Broader and more advanced clinical value proposition compared to some competitors, encompassing various disease states.
  • FDA-cleared analytics and digital biomarkers are crucial for clinical credibility.

Limitations

  • Pricing requires direct contact, lacking immediate transparency.
  • Specific support details are not publicly detailed.
  • No ratings yet on Physician AI Tools, G2, or Capterra for this specific module.
  • Some general Physiq (fitness) reviews on Reddit and BBB indicate issues with customer service, billing, and gym management, though these are not specific to the medical module.

Based on reviews from: Physician AI Tools, Orthogonal, Chicago Innovation, MDPI, PMC, Reddit, FDA Radiology AI Device - X-ray Interpreter

Last updated: 2026-07-20

Ratings & Reviews

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Press & Coverage

RadAI Slice
physIQ Heart Rhythm and Respiratory Module | FDA Radiology AI Device - X-ray Interpreter
The physIQ Heart Rhythm and Respiration Module is a software device that analyzes ECG signals and movement data to calculate heart rate, heart rate variability, detect atrial fibrillation, and determine respiration rate. It received FDA 510(k) clearance on July 10, 2019.
2019-07
FDA
K183322 - 510(k) Premarket Notification - FDA
This is the official FDA 510(k) premarket notification for the physIQ Heart Rhythm and Respiratory Module, detailing its applicant, contact information, regulation number, and product code. The document confirms the device's clearance for calculating heart rate and heart rate variability, detecting atrial fibrillation, and determining respiration rate.
2019-07
Frontiers in Digital Health (PMC)
Artificial Intelligence in Perioperative Medicine: A Proposed Common Language With Applications to FDA-Approved Devices - PMC
This peer-reviewed article discusses FDA-approved AI algorithms in perioperative medicine, categorizing the physIQ Heart Rhythm and Respiratory Module as 'translucent' due to its ability to collapse heart failure-related factors into a single index viewable by patients and providers. It highlights the module's function in detecting atrial fibrillation using a patient's own baseline.
2022-03
Journal of Medical Investigation (PMC)
Computational healthcare: Present and future perspectives (Review) - PMC
This review of computational healthcare and AI applications lists the physIQ Heart Rhythm and Respiratory Module as an FDA-approved device from 2019, used for diagnosis in cardiology. It places the module within the context of AI's expanding role in healthcare, including diagnosis, treatment, and follow-up.
2021-07
ResearchGate (IQVIA Institute for Human Data Science)
Digital Health Trends 2024 - ResearchGate
The 'Digital Health Trends 2024' report mentions the physIQ Heart Rhythm and Respiratory Module in a list of digital health solutions. This report provides an overview of trends in digital health, including diagnostics, therapeutics, and remote patient monitoring tools.
2023-12
Nature Communications (PMC)
Continuous vital sign monitoring of acute Lassa fever using wearable biosensor devices in West Africa - PMC
This research article, published in Nature Communications, cites the FDA premarket notification (K183322) for the physIQ Heart Rhythm and Respiratory Module in the context of continuous vital sign monitoring using wearable biosensor devices. The study explores the use of such devices for monitoring acute Lassa fever.
2025-07
FDA
TPLC - Total Product Life Cycle - FDA
The FDA's Total Product Life Cycle (TPLC) database entry for the physIQ Heart Rhythm and Respiratory Module (K183322) confirms its regulatory status as an electrocardiograph. This entry also lists related physIQ modules and other substantially equivalent devices.
2026-07
Frontiers in Oncology (PMC)
Application of Artificial Intelligence Technology in Oncology: Towards the Establishment of Precision Medicine - PMC
This article on AI in oncology lists the physIQ Heart Rhythm and Respiratory Module (K183322) as an FDA-approved AI-equipped medical device from 2019. It highlights the device's role in calculating heart rate and variability, detecting atrial fibrillation, and determining respiration rate.
2023-05

Videos

Product demos, reviews, and walkthroughs for physIQ Heart Rhythm and Respiratory Module.

View all on YouTube

Frequently Asked Questions

The physIQ Heart Rhythm and Respiratory Module is designed to be integrated by the customer organization into an end-to-end system, from biosensor data collection to clinician display. It supports receiving and analyzing single-lead ECG signals and triaxial accelerometer data from compatible, FDA-cleared chest-worn biosensors using 'wet electrode' technology. The platform uploads raw telemetry to the cloud for analysis, with outputs returned to middleware for insertion into downstream monitoring systems for clinical use.
The module continuously monitors and analyzes heart rate, heart rate variability, and respiration rate. It also detects atrial fibrillation using ambulatory ECG and triaxial accelerometer data. The AI-powered analytics transform this real-world data into actionable clinical insights by learning a patient's personalized baseline and identifying subtle physiological changes.
Yes, the physIQ Heart Rhythm and Respiratory Module (Version 3.0) has received FDA 510(k) clearance. It is intended for use by physicians or other qualified medical professionals for calculating heart rate and heart rate variability, detecting atrial fibrillation, and determining respiration rate using ambulatory ECG and triaxial accelerometer data in adult patients in subacute clinical and nonclinical settings for remote patient monitoring.
While specific details on physIQ's HIPAA compliance for this module are not explicitly detailed in public search results, as a medical device handling Protected Health Information (PHI), physIQ must adhere to HIPAA regulations. This typically involves ensuring robust physical, network, and process security measures, encrypting data transmission, limiting access to authorized healthcare providers, and obtaining patient consent for data use and protection. physIQ's platform is also described as CFR Part 11-compliant for clinical trials, indicating strong data integrity and security protocols.
The physIQ module differentiates itself by utilizing continuous, real-time physiological data from medical-grade biosensors combined with FDA-cleared AI analytics. Unlike traditional RPM which may rely on periodic measurements, physIQ's AI establishes a personalized dynamic baseline for each patient, enabling the detection of subtle deviations that may precede disease exacerbation or changes in health. This approach aims to provide proactive insights beyond simple vital sign collection.
Specific pricing structures for the physIQ Heart Rhythm and Respiratory Module are not publicly disclosed in the available information. Interested healthcare providers or organizations would need to contact physIQ directly for detailed pricing models, which may vary based on factors such as practice size, patient volume, and integration requirements.
The module is intended for adult patients in subacute clinical and nonclinical settings for remote monitoring and is explicitly not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices, nor for critical care patients. While the AI is designed to manage signal noise, respiration rate measurement can be challenging in real-world environments due to motion artifacts. The system relies on data from specific FDA-cleared, chest-worn biosensors using 'wet electrode' technology.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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