Biobeat

by Biobeat Technologies  · Based in Israel → — FDA Cleared Cuffless Ambulatory Blood Pressure Monitoring
Cardiology Hospital Medicine Internal Medicine

Regulatory Status Disclosed

Overview

Biobeat is a medical technology company specializing in FDA-cleared, cuffless blood pressure monitoring solutions. The company’s remote patient monitoring (RPM) health-AI platform utilizes proprietary patented PPG (photoplethysmography) sensors integrated into wearable devices, including a disposable chest patch and a reusable wrist monitor. These devices continuously track up to 13 vital signs, such as cuffless blood pressure, pulse rate, respiratory rate, blood oxygen saturation, temperature, stroke volume, cardiac output, and one-lead ECG (chest monitor only).

Biobeat’s platform is designed to revolutionize hypertension diagnosis and management by providing accurate, real-time data without the discomfort and interruption of traditional cuff-based methods. The aggregated patient health data is transmitted to a secure, HIPAA and GDPR compliant cloud-based patient management platform. This platform features an automated real-time early warning score (EWS) system that incorporates advanced AI-based algorithms to identify early patient deterioration and provide actionable insights for proactive care. The system aims to enhance clinical decision-making, improve patient compliance, and support both in-hospital and home-based care settings.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Cuffless blood pressure monitoring
  • Continuous vital sign tracking (13 parameters)
  • Wearable chest patch and wrist monitor
  • AI and machine learning analytics
  • Real-time early warning score (EWS) system
  • Cloud-based patient management platform
  • Mobile app connectivity (iOS/Android)
  • EMR/EHR integration (e.g., Epic)
  • Secure data transmission (HIPAA/GDPR)
  • Automated report generation

Use Cases

  • Hypertension diagnosis and management
  • In-hospital monitoring
  • Hospital-at-home programs
  • Ambulatory services
  • Decentralized clinical trials
  • Long-term care for chronic conditions

What Physicians Need to Know

ECG/EKG Analysis Capability
Biobeat's chest monitor device includes one-lead EKG capabilities.
Arrhythmia Detection Accuracy
Biobeat devices are FDA-cleared and CE Mark certified for arrhythmia detection. The use of Biobeat's RPM devices in cardiovascular disease can lead to early detection of arrhythmia to enable faster interventions.
Heart Failure Risk Prediction
Biobeat's continuous noninvasive wearable multi-parameter monitoring wrist device provides critical insights for clinicians determining the course of treatment and heart failure patient prognosis. A peer-reviewed study validated the use of Biobeat's wrist monitor for advanced noninvasive hemodynamic monitoring in heart failure patients. Biobeat's research on noninvasive cardiac flow assessment has been published in JACC: Advances, highlighting the clinical value of their PPG device for heart failure patients. The use of RPM devices in CVD can predict heart failure decompensation.
Coronary Artery Assessment
Biobeat's devices measure various hemodynamic parameters such as stroke volume, cardiac output, cardiac index, and systemic vascular resistance, which can provide insights into cardiovascular function.
Cardiac Monitoring Integration
Biobeat offers continuous monitoring of 15 cardio-pulmonary vital signs, including cuffless blood pressure, pulse rate, respiratory rate, blood oxygen saturation, stroke volume, cardiac output, cardiac index, systemic vascular resistance, and skin temperature. The platform provides real-time data and alerts to medical staff, enabling early identification of clinical deterioration.
AHA/ACC Guideline Alignment
Biobeat's cuffless 24-hour blood pressure monitoring platform aligns with AHA/ACC guidelines that recommend 24-hour ambulatory blood pressure monitoring (ABPM) to confirm hypertension diagnosis. The platform helps address the challenge of underutilization of traditional cuff-based ABPM, which is the diagnostic gold standard according to ACC/AHA guidelines.
Real-Time Alert Capability
Biobeat's cloud-based patient management system provides medical staff with real-time data and alerts, enabling early identification of clinical deterioration. The platform utilizes an automated real-time early warning score (EWS) system that incorporates advanced AI-based algorithms to provide alerts on patient health status and potential deterioration. This system has shown to outperform currently used tools in providing timely alerts of pre-symptomatic and real-time deterioration. The integration of wireless sensor technology with automatic alert generation creates a holistic and proactive approach to patient care.
Physician Tip

Biobeat's continuous, cuffless monitoring offers a more complete picture of a patient's cardiovascular health, especially for hypertension diagnosis and management, by capturing vital signs throughout the day and night, including during sleep. This can help overcome the limitations of single office readings, such as white-coat hypertension or masked hypertension, and identify abnormal nocturnal blood pressure patterns linked to increased cardiovascular risk. The AI-powered early warning scores and real-time alerts can aid in proactive intervention and personalized treatment decisions. The integrated patient diary allows for correlation of physiological changes with daily activities, meals, stress, and sleep quality, providing deeper insights into blood pressure fluctuations. While the cuffless device offers convenience and improved patient compliance, especially for 24-hour monitoring, it's important to remember that it estimates pressure continuously rather than inflating a cuff for each reading, and results are best treated as a detailed screen rather than a final diagnosis for new conditions.

Biobeat's platform is designed for integration into existing healthcare workflows. It has successfully integrated with Epic EHR systems, allowing seamless transfer of vital sign data from Biobeat RPM devices to the Electronic Health Record, which can streamline workflow and save time for medical staff. Biobeat also partners with platforms like Current Health (Best Buy Health) for care-at-home solutions and Datos Health for managing high-acuity remote care programs. Additionally, Biobeat is part of the Medidata Solutions Sensor Cloud Network, facilitating data collection in decentralized clinical trials. The system supports EMR integration and secure data transmission (HIPAA/GDPR compliant).

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Unknown
  • Subscription models for continuous access to monitoring software; one-time purchases and recurring service fees for devices
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated

Biobeat's wearable monitoring devices are FDA-cleared for cuffless blood pressure monitoring from photoplethysmography (PPG) only, and for monitoring stroke volume, cardiac output, blood oxygen saturation, pulse rate, respiratory rate, and body temperature.

Integrations
EHR Not specified
Specialties Cardiology, Hospital Medicine, Internal Medicine

What the Web Says

Biobeat offers wearable monitoring devices, such as wrist and chest monitors, that provide continuous, real-time tracking of 13 vital signs using proprietary PPG sensor technology. The system is utilized for in-hospital, ambulatory, and remote patient monitoring, supporting applications like early deterioration detection, personalized care, and clinical research. Physicians generally praise the comfort and convenience of Biobeat's devices compared to traditional methods, especially for 24-hour blood pressure monitoring, and acknowledge its FDA approval for wrist-based blood pressure measurement.

Overall: Mixed

Strengths

  • Continuous, real-time tracking of 13 vital signs.
  • Proprietary PPG sensor technology for accurate measurements.
  • FDA-approved for wrist-based blood pressure measurement.
  • More comfortable and convenient than traditional cuff-based devices for prolonged monitoring.
  • Provides an AI-derived Early Warning Score for patient decline.
  • Detailed and easy-to-understand PDF reports.
  • Effectively utilized across various clinical settings with positive patient outcomes.

Limitations

  • Lack of access outside of a medical setting; not sold for non-medical use.
  • Does not have an emergency alarm system in place; relies on periodic nurse checks.
  • Uncertainty regarding system behavior when pulse is 0 bpm.
  • Expensive (around $1800 per device).
  • 24-hour patch is a single-use device with a non-removable/non-rechargeable battery.
  • Some studies found substantial data loss and variable agreement with nurse measurements across vital signs.
  • Potential for discrepancies in blood pressure readings compared to other home monitors.

Based on reviews from: Review: Biobeat Monitoring System, A 24-Hour Skin Patch That Monitors Blood Pressure: The BioBeat Review, BioBeat review on blood pressure monitors using a skin patch., Biobeat monitor utilization in various healthcare settings: A systematic review - PubMed, Biobeat Reviews, Pricing, Features & Integrations - Elion Health, A 24-Hour Skin Patch That Monitors Blood Pressure: The BioBeat Review - Medigy, Biobeat monitor utilization in various healthcare settings: A systematic review - ResearchGate, Biobeat 24BP 24hr ABPM blood pressure monitor : r/bloodpressure - Reddit, Accuracy of Biobeat : r/medical - Reddit, Anyone have experience with the 24 hr Biobeat patch/app : r/bloodpressure - Reddit, Biobeat Test - Instalab, Accuracy of Biobeat 24 hour blood pressure patch? : r/medical - Reddit, How accurate is the Biobeat patch and app? : r/medical_advice - Reddit, Continuous remote monitoring of postoperative vital signs with the Biobeat patch: A multicenter prospective observational study - PMC, Clinical Study Highlights Accuracy of Biobeat's Wearable Cuffless Blood Pressure Monitoring Device When Compared To Traditional Cuff-Based Devices - PR Newswire, Biobeat's Smart 24-hour Blood Pressure Monitoring Device Helps Doctors Save Lives - Jewish Press - Tampa Edition

Last updated: 2026-07-27

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Press & Coverage

Biobeat (Press Release)
Biobeat Secures $50 Million Series B Financing to Advance Commercialization of its Patch-worn, Cuffless 24-hour Ambulatory Blood Pressure Monitor
Biobeat Technologies announced a $50 million Series B equity financing round to expand the commercialization of its FDA-cleared, patch-worn, cuffless 24-hour ambulatory blood pressure monitoring (ABPM) system in the United States. The funding was led by Ally Bridge Group, OrbiMed Advisors, and Elevage Medical.
2025-12
MedTech Dive
Biobeat raises $50M to commercialize cuffless blood pressure monitor
Biobeat Technologies secured $50 million in Series B funding to commercialize its cuffless blood pressure monitor in the U.S. The company's 24-hour ambulatory blood pressure monitoring patch aims to improve compliance compared to traditional cuff-based devices.
2026-01
Fierce Biotech
Biobeat Technologies drums up $50M for its cuffless blood pressure monitor
Biobeat Technologies raised $50 million in a Series B round to boost the commercialization of its FDA-cleared, 24-hour patch-worn device for diagnosing and treating high blood pressure. The cuffless device uses photoplethysmography sensors for continuous, comfortable measurements.
2026-01
Biobeat (White Paper)
Clinical Validation That Matters: Biobeat's Latest White Paper
Biobeat's latest white paper details the rigorous clinical validation of its FDA-cleared, medical-grade, cuffless PPG-based chest patch, including a Mayo Clinic study demonstrating strong correlation with invasive arterial blood pressure monitoring. This highlights the technology's accuracy and reliability for hypertension management.
2026-06
PubMed (Digit Health)
Biobeat monitor utilization in various healthcare settings: A systematic review
This systematic review demonstrates that Biobeat's non-invasive wearable devices have been effectively utilized across various clinical settings, consistently contributing to positive patient outcomes. The review included 15 studies involving 4248 patients, showcasing the versatility and reliability of the devices.
2025-02
Biobeat (Press Release)
Biobeat Medicalu2011Grade Monitoring Devices and Platform Receive FDA Clearances for Stroke Volume and Cardiac Output
Biobeat announced that its wearable monitoring devices received 510(k) clearance from the FDA to monitor stroke volume and cardiac output, in addition to previously cleared vital signs. This expands the capabilities of their cuffless monitoring solutions for cardiac patients.
2023-01
PR Newswire
FDA Clears the Biobeat Remote Patient Monitoring Device and Platform for Additional Vital Signs
Biobeat received 510(k) clearance from the FDA for its wearable remote patient monitoring devices to monitor respiratory rate and body temperature, in addition to cuffless blood pressure, blood oxygen saturation, and pulse rate. This brings the total FDA-cleared vital signs to five.
2022-03
Biobeat (News)
Biobeat's Latest Research Published in JACC Journals: Advances
Biobeat's research, published in JACC Journals: Advances, validates the accuracy of its noninvasive photoplethysmography (PPG) device for cardiac flow measurements, showing a strong correlation with invasive pulmonary artery catheter measurements in heart failure patients.
2025-08

Videos

Product demos, reviews, and walkthroughs for Biobeat.

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Frequently Asked Questions

Biobeat employs end-to-end encryption for all data transmission and storage, adhering to stringent security protocols. Our systems are designed to be fully HIPAA compliant, with regular audits and certifications to ensure patient data remains private and secure at all times.
Biobeat offers continuous, cuffless, and wireless monitoring of 16 vital signs, including continuous blood pressure, without the need for patient interaction. This provides a more comprehensive and real-time view of patient health compared to intermittent measurements, and our AI-driven analytics offer predictive insights not typically available with basic RPM platforms.
Biobeat's technology has undergone extensive clinical validation, with numerous peer-reviewed studies demonstrating its accuracy against gold-standard medical devices. Our continuous blood pressure monitoring, for example, has received FDA clearance and CE mark based on rigorous clinical trials.
Pricing for Biobeat's system varies based on the scale of implementation and specific features required. We offer flexible models and can provide detailed cost breakdowns upon consultation. Many of Biobeat's RPM capabilities are eligible for reimbursement under existing CPT codes, and we can assist practices in navigating these options.
While Biobeat is highly versatile, certain extreme skin conditions or anatomical variations might affect sensor adherence or signal quality. It's important to consider these factors during patient selection, and our support team provides guidance on optimal device placement and data interpretation in various scenarios.
Biobeat offers robust API integrations with most major EHR systems, allowing for seamless data flow directly into patient records. Our platform can be configured to generate customized alerts and notifications based on predefined thresholds, ensuring physicians are promptly informed of any significant changes in a patient's vital signs.
Biobeat provides comprehensive training programs for all healthcare staff, covering device usage, platform navigation, and interpretation of AI-driven insights. We also offer ongoing technical support, including dedicated account managers and 24/7 assistance, to ensure smooth operation and maximize the benefits of our system.

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Suggest an Edit → | Last Verified: 2026-07-26 | First Added: 2026-07-26
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