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
The physIQ Heart Rhythm and Respiratory Module is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation through automated analysis of single-lead ECG data. It supports receiving and analyzing single-lead ECG signals from FDA-cleared ECG biosensor devices using "wet" electrode technology.
Arrhythmia Detection Accuracy
The module includes algorithms for Atrial Fibrillation detection. Performance testing for these algorithms follows guidelines of ANSI/AAMI EC57: Testing and Reporting Performance Results of Cardiac Rhythm and ST segment Measurement Algorithms. The AFib detection analytic has received FDA 510(k) clearance.
Heart Failure Risk Prediction
PhysIQ's analytics can detect subtle deviations in vital signs that may precede disease exacerbation or changes in health. The company's platform has demonstrated the ability to predict heart failure rehospitalization approximately one week before it occurs, with high sensitivity (76-88%) and specificity (85%).
Cardiac Monitoring Integration
The physIQ Heart Rhythm and Respiratory Module is intended to be integrated by customer organizations into an end-to-end system, from biosensor data collection to clinician display. It processes multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. The platform collects raw telemetry from wearable devices and uploads it to the cloud for analysis.
Real-Time Alert Capability
The platform's analytics detect subtle deviations that may be a precursor to disease exacerbation or change in health, which can be used to generate alerts. In a study, the system predicted heart failure hospitalization with a median time between initial alert and readmission of 6.5 days.
Physician Tip

The physIQ Heart Rhythm and Respiratory Module is a software-only solution designed for remote patient monitoring in subacute clinical and non-clinical settings. It is crucial to integrate this module with FDA-cleared, chest-worn biosensors using "wet" electrode technology that capture single-lead digital ECG data and triaxial accelerometer data. The module is not intended for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices. Physicians should utilize the calculated heart rate, heart rate variability, atrial fibrillation detection, and respiration rate outputs in conjunction with their clinical judgment and other diagnostic information. The system's ability to detect subtle physiological changes and predict heart failure rehospitalization can be a valuable tool for proactive patient management and potentially reducing readmissions.

The physIQ Heart Rhythm and Respiratory Module is a computerized, all-software callable function library in Python. It is designed for integration into a customer's end-to-end system (biosensor data collection to clinician display). This integration typically occurs via a Python middleware script that accesses source ECG and triaxial accelerometer data from the customer's data collection system (likely through its API) and then calls the physIQ module for processing. The processed vital sign outputs are then returned to the middleware for insertion into a downstream monitoring system for clinical use. The platform is device-agnostic, allowing for flexibility in compatible wearable sensors.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentCloud-based platform
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
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 library designed for physicians and qualified medical professionals. It analyzes single-lead ECG and triaxial accelerometer data from compatible FDA-cleared biosensors to calculate heart rate, heart rate variability, detect atrial fibrillation, and determine respiration rate. The module is intended for remote patient monitoring in subacute clinical and non-clinical settings, but not for patients requiring life-sustaining systems or ECG alarm devices.

Overall: Positive

Strengths

  • FDA-cleared for heart rate, heart rate variability, atrial fibrillation detection, and respiration rate.
  • Utilizes AI and machine learning for personalized physiology analytics.
  • Cloud-based analytics leverage superior computing power for accurate vital sign analysis, especially for respiration rate in noisy environments.
  • Designed for integration into end-to-end remote patient monitoring systems.
  • Supports proactive and predictive insights by detecting subtle deviations from a personalized baseline.
  • Device-agnostic platform that can process data from various FDA-cleared wearable biosensors.

Limitations

  • Not for use in patients requiring life-supporting or life-sustaining systems or as ECG/respiration alarm devices.
  • Requires FDA-cleared, chest-worn biosensors using "wet electrode" technology for data input.
  • No direct user reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found for this specific module.
  • The module is a software library intended for integration by customer organizations, not a standalone end-user product.
  • Limited information available regarding ease of integration or specific user experience from healthcare professionals.

Based on reviews from: innolitics.com, mpo-mag.com, mdpi.com, nih.gov, fda.gov, orthogonal.io, fda.report, chicagoinnovation.com, chiefhealthcareexecutive.com, aviahealth.com, indeed.com, medicalalley.org, wearable-technologies.com, reddit.com

Last updated: 2026-10-31

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Press & Coverage

FDA
physIQ Heart Rhythm and Respiratory Module
This FDA 510(k) Premarket Notification document details the clearance of the physIQ Heart Rhythm and Respiratory Module by Physiq, Inc. It lists the applicant, contact information, regulation number, and classification product code.
2019-07
Experimental and Therapeutic Medicine (via NIH)
Artificial intelligence in healthcare: Past, present and future
This peer-reviewed article discusses the history, current state, and future of AI in healthcare, mentioning the physIQ Heart Rhythm and Respiratory Module as an FDA-approved AI-based application for diagnosis in cardiology from 2019.
2021-09
MDPI - Cancers
Artificial Intelligence in Oncology: Current Applications and Future Perspectives
This peer-reviewed article on AI in oncology lists the physIQ Heart Rhythm and Respiratory Module as one of over 60 AI-powered medical devices approved by the US FDA as of 2020. It describes the device's function in calculating heart rate, heart rate variability, detecting atrial fibrillation, and determining respiration rate.
2020-11
Frontiers in Digital Health (via NIH)
A Nomenclature for Describing Algorithm Implementations in Perioperative Medicine
This peer-reviewed article proposes a nomenclature for describing algorithm interpretability in perioperative medicine. It categorizes the physIQ Heart Rhythm and Respiratory Module as 'translucent' because it provides predictions alongside features considered, allowing patients and providers to view signals related to a heart failure index.
2022-03
ResearchGate (IQVIA Institute for Human Data Science)
Digital Health Trends 2024: Implications for Research and Patient Care
This report on digital health trends mentions the physIQ Heart Rhythm and Respiratory Module in the context of various digital health solutions and their market presence. It broadly covers digital diagnostics, therapeutics, and remote patient monitoring tools.
2023-10
Physician AI Tools
physIQ Heart Rhythm and Respiratory Module vs KardiaPro
This comparison article evaluates the physIQ Heart Rhythm and Respiratory Module against KardiaPro, highlighting physIQ's continuous, long-term remote monitoring capabilities using wearable biosensors for early detection of physiological changes and decompensation.
unknown
Physician AI Tools
physIQ Heart Rhythm and Respiratory Module vs VX1
This comparison details the physIQ Heart Rhythm and Respiratory Module against VX1, emphasizing physIQ's AI-based personalized physiology analytics, ability to learn individual patient baselines, and its functions in detecting subtle physiological changes, heart rate, heart rate variability, atrial fibrillation, and respiration rate.
unknown

Videos

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Frequently Asked Questions

The physIQ Heart Rhythm and Respiratory Module is intended for use by qualified medical professionals to calculate heart rate and heart rate variability, detect atrial fibrillation, and determine respiration rate using ambulatory ECG and triaxial accelerometer data. It is designed for remote patient monitoring in subacute clinical and non-clinical settings for adult patients. It is not intended for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.
The physIQ Heart Rhythm and Respiratory Module (Version 3.0) received 510(k) clearance from the FDA in June 2020. Earlier versions also received FDA 510(k) clearance, including for continuous ambulatory respiration rates in August 2019. To ensure HIPAA compliance, ECG data, as electronic Protected Health Information (ePHI), must be safeguarded with administrative, physical, and technical controls, including formal risk analysis, written policies, workforce training, and vendor oversight. Encryption standards like AES-256 for data at rest and TLS 1.2/1.3 for data in transit are expected.
The physIQ Heart Rhythm and Respiratory Module utilizes AI and machine learning analytics to process physiological data from wearable sensors, creating a personalized dynamic baseline for each individual. This approach allows for the detection of subtle deviations that may precede disease exacerbation. While traditional Holter monitors provide comprehensive data, AI tools like physIQ's aim to offer continuous, cloud-based analysis, potentially identifying subtle abnormalities that might be missed by conventional systems. Other AI tools, such as PMCardio, have shown higher diagnostic accuracy than healthcare professionals in interpreting ECGs, though they may take longer.
The physIQ Heart Rhythm and Respiratory Module is not for use in patients who require life-supporting or life-sustaining systems or as ECG or respiration alarm devices. It is also not intended for use in emergency situations. It must be used with FDA-cleared, chest-worn biosensors that use "wet electrode" technology and capture single-lead digital ECG data and integrated triaxial accelerometer data in a compatible format.
Specific pricing for the physIQ Heart Rhythm and Respiratory Module is not publicly available. However, for remote patient monitoring (RPM) solutions in general, costs can include hardware, data transmission fees, software connectivity fees, and support. Medicare reimbursement for a fully enrolled RPM patient can generate $150 to $200 or more per month, with software platform fees adding $10 to $40 per patient per month. This suggests a potential profit margin for practices utilizing RPM.

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