BioBeat — CBP Monitor

Company Overview

BioBeat Technologies Ltd. is an Israeli digital health company founded in 2016, headquartered in Petach Tikva, Israel, specializing in FDA-cleared cuffless blood pressure monitoring using advanced photoplethysmography (PPG) technology.

Founded by Arik Ben Ishay, Israel Sarussi, Johanan May, and Lior Ben Shettrit, BioBeat made history in August 2019 when it became the first company to receive FDA clearance (K181006) for cuffless blood pressure monitoring from PPG alone. This groundbreaking achievement positioned BioBeat as a pioneer in non-invasive continuous vital signs monitoring.

The company has raised approximately $21.8M from investors including BestBuy Health, BeyondBio (Israel), L Marks, Menomadin Foundation, Florida-Israel Business Accelerator, ARC Innovation at Sheba Medical Center, and Hangar 51. BioBeat has since expanded its regulatory clearances with K212153 (March 2022) for respiratory rate and body temperature monitoring, and K212957 (December 2022) for the BioButton System extending monitoring up to 60 days.

Technical Specifications

4

LED Array

±5

mmHg BP

60

Days Battery

0-299

mmHg Range

BT4.2

Protocol

IP47

Rating

Core Technology

PPG-Based Pulse Wave Transit Time (PWTT)

BioBeat's devices use proprietary reflective photoplethysmography (PPG) technology with AI-powered analytics to deliver continuous, real-time measurements. The system features a four LED array (650nm Red + 880nm IR) with photodiode sensors that absorb reflected light from tissue to measure arterial oxygen saturation, pulse rate, and blood pressure changes. Blood pressure tracking is achieved by calculating PWTT using pulse measurements from the integrated SpO2 sensor, following a calibration process with an FDA-cleared oscillometric blood pressure monitor. This method measures the time it takes for the pulse wave to travel from the heart to the measurement site.

Multi-Parameter Continuous Monitoring

The BioBeat Platform continuously measures multiple vital signs: blood pressure (±5 mmHg accuracy, 0-299 mmHg range), heart rate (40-250 bpm, ±3% accuracy), respiratory rate (4-40 RPM, ±3 RPM accuracy measured by analyzing cyclic variations in the photoplethysmogram), SpO2 (40-100%, ±2% accuracy), and body temperature (32-42°C, ±0.3°C using integrated thermistors). The system uses wireless Bluetooth 4.2 transmission to gateway devices and cloud platforms for data storage and analysis. All measurements require calibration against an oscillometric reference device and are intended for spot-checking while the patient is at rest.

Dual Form Factors: Wristwatch and Chest Patch

BioBeat offers two main device form factors optimized for different use cases. The BB-613WP Wristwatch provides 72-hour battery life and can be worn on the wrist or attached to skin using a biocompatible adhesive unit. The BB-613WP Patch offers 120-hour battery life and attaches to the chest skin using a hydrocolloid adhesive. The newer BioButton System extends battery life up to 60 days for long-term monitoring applications. Both devices measure 41.2x37.5x5.7mm (BioButton) and weigh between 9.4g-23g, using polycarbonate, photodiode window, and silicone materials with IP47 ingress protection.

Clinical Performance

±5

mmHg BP

Accuracy

±3%

Heart Rate

Accuracy

±2%

SpO2

70-100% Range

2019

First FDA

Clearance

FDA Clinical Validation Studies

BioBeat's clinical validation studies demonstrated substantial equivalence to predicate oximeters and blood pressure monitors. Clinical validation of the oximeter was performed per FDA pulse oximeter guidance on 10 patients with varying Fitzpatrick skin types (I-V), ages 18-40, with 6 male and 4 female subjects. Testing showed equivalence to simultaneous measurements from predicate devices. The pulse rate validation was conducted per ISO 80601-2-61 using a custom-built simulator for reflectance oximetry. No adverse events were observed during testing.

Accuracy Across Multiple Parameters

The BB-613 devices measure blood pressure in the range of 0-299 mmHg with ±5 mmHg accuracy, tracking changes based on PWTT following calibration with an oscillometric reference device. SpO2 measurements achieve ±3% accuracy for 70-100% range (±2% for 70-80% specifically), equivalent to predicate devices like the Oxitone 1000 (K163382). Respiratory rate achieves ±3 RPM accuracy in the 4-40 RPM range while the patient is at rest. Body temperature measurements meet ASTM E1112-00 standard in the 86-107°F (30-42°C) range with ±0.3°C accuracy calculated from skin temperature and ambient temperature.

Safety and Regulatory Compliance

All BioBeat devices comply with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use), and ISO 10993 biocompatibility standards for permanent contact with intact skin. The devices have undergone cytotoxicity, sensitization, and irritation testing per ISO 10993-5 and 10993-11 to evaluate permanent contact of silicone, polycarbonate, carbon black, and stainless steel with intact skin. Software validation was performed per FDA guidance including cybersecurity assessment. The devices are classified as Class II, Type BF applied parts for spot measurement in hospitals, clinics, long-term care, and home use for adults 18+ years.

Market Position & Competition

First-Mover Advantage: BioBeat holds the distinction of being the first FDA-cleared cuffless blood pressure monitoring system using PPG technology alone (August 2019). This first-mover advantage has established BioBeat as a benchmark in the cuffless BP monitoring space, with three 510(k) clearances spanning watch, patch, and extended-duration button form factors.

Target Markets: The BioBeat Platform is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and home use. The devices are specifically not intended for critical care patients and require patients to be at rest for accurate measurements. Primary use cases include remote patient monitoring (RPM), post-operative care, chronic disease management (hypertension, heart failure), and telehealth applications. The BioButton System's 60-day battery life makes it particularly suitable for extended monitoring periods in clinical trials and longitudinal studies.

Competitive Positioning: BioBeat competes against both traditional oscillometric devices and emerging cuffless technologies. Direct competitors include Aktiia (optical PPG, calibration-free), Omron (oscillometric cuffs), and other PPG-based systems. Key differentiators include FDA clearance for multiple form factors, continuous monitoring capability, multi-parameter measurement (BP, HR, RR, SpO2, temperature), and the flexibility to choose between wrist-worn and chest-patch configurations based on clinical requirements. The requirement for oscillometric calibration positions BioBeat between fully calibration-free systems and traditional cuff-based monitoring.

2025 Developments: BioBeat introduced its next-generation wearable biosensor in 2025, representing a state-of-the-art cuffless, wireless solution that redefines continuous vital signs measurement across healthcare settings. The company continues to expand clinical evidence through systematic reviews published in academic journals, with one 2025 publication examining BioBeat monitor utilization across various healthcare settings demonstrating broad adoption in hospitals, post-acute care, and home monitoring scenarios.

Strategic Assessment

BioBeat demonstrates that PPG-based PWTT methodology can achieve regulatory clearance for cuffless blood pressure monitoring, establishing a pathway for continuous vital signs platforms, though calibration requirements and spot-measurement limitations constrain market positioning.

The company's three 510(k) clearances spanning 2019-2022 demonstrate sustained regulatory success and iterative product development. The expansion from basic oximetry (K181006) to multi-parameter monitoring including respiratory rate and temperature (K212153) to extended 60-day battery life (K212957) shows strategic product evolution. The Israeli-to-US regulatory pathway via Hogan Lovells LLP representation indicates sophisticated commercialization strategy.

However, fundamental limitations exist. The requirement for oscillometric calibration reduces the convenience advantage versus traditional monitors. Spot-measurement-only clearance (not continuous) limits use cases despite 60-day battery capability. The "at rest" restriction excludes ambulatory monitoring scenarios that represent the largest market opportunity for wearables. IP47 rating restricts waterproofing versus IP67+ competitors.

BioBeat's success factors include: (1) Regulatory expertise enabling first-to-market clearance that creates moat, (2) Multi-form-factor strategy (watch, patch, button) addressing different clinical workflows, (3) Platform approach combining hardware with cloud infrastructure, (4) Israeli medical device ecosystem providing R&D talent and early customers. The $21.8M funding level suggests pre-commercial or early-commercial stage requiring additional capital for scaling.

Strategic risks include competition from calibration-free systems (Aktiia), larger players entering cuffless space (Omron, Samsung), and uncertain reimbursement pathways for cuffless monitoring. The technology serves as validation that PPG+PWTT can achieve regulatory acceptance, but the calibration requirement and spot-measurement limitation suggest current approach represents transitional technology rather than endpoint solution. Most likely outcome: acquisition by larger medical device or consumer health company seeking regulatory-cleared cuffless BP technology to integrate into existing product lines.