Clinical Analytics & Validation

Corsano Vital Parameters

Clinically validated, CE-MDR certified, and FDA cleared algorithms delivering up to 19 continuous physiological metrics for hospital general wards, RPM, and life sciences trials.

Regulatory & Monitoring Overview

Comprehensive Clinical Parameter Specifications

The CardioWatch 287 system processes raw multi-sensor data through proprietary firmware and cloud algorithms. Designed under ISO 13485 quality standards, Corsano delivers high-precision continuous metrics alongside integrated third-party spot-check device data into hospital EMR systems.

Vital Parameter	Algorithm Source	CE-MDR (EU)	FDA 510(k) (US)	Monitoring Mode
Pulse Rate (PR)	Corsano Firmware Proprietary	✓	✓	Continuous
Oxygen Saturation (SpO2)	Corsano Pulse Oximetry FW	✓	✓	Continuous
Respiration Rate (RR)	Corsano Time-Frequency FW	✓	✓	Intermittent / Continuous Trend
Skin Temperature (sTemp)	Direct Surface Thermal Probe	✓	✓	Continuous
Core Body Temp (CBT)	GreenTEG Heatflux + PPG Algo	✓	Pending / Research	Continuous (EU Only)
Cuffless NIBP	Corsano PPG Waveform AI (Cloud)	✓	Pending / Research	Continuous (EU Only)
Single-Lead ECG	Corsano SQ + CardioLyse	✓	Pending / Research	On-Demand Strip (EU Only)
Atrial Fibrillation (AFIB)	Corsano PPG & ECG Algorithms	✓	Pending / Research	Continuous Passive Screening
Sleep Stages & Wake	Cole-Kripke Actigraphy & PPG	✓	✓	Nocturnal Continuous
Activity Steps	3-Axis Accelerometer FW	✓	✓	Continuous Expenditure
NIBP Cuff (Spot-check)	External Bluetooth Cuff	✓	✓	Episodic 3rd-Party

Engineering & Algorithmic Principles

Validated Sensing Methods & Accuracy Specs

Every algorithm inside the Corsano CardioWatch platform undergoes rigorous benchmark testing against gold-standard invasive and clinical reference tools.

Pulse Rate (PR) & Pulse Oximetry (SpO2)

Utilizing multi-wavelength Photoplethysmography (PPG) with red (660nm), infrared (880nm), and green (525nm) LEDs, the wrist sensor measures pulsatile blood volume changes. Integrated 3-axis accelerometer signals (sampled at 32Hz) actively cancel motion artifacts.

PR Range & Accuracy: 25 to 250 bpm; <3 bpm Arms (<1 bpm Arms in supine/prone positions).
SpO2 Range & Accuracy: 70% to 100%; <2% Arms versus invasive arterial SaO2 co-oximetry.
Data Update Interval: Calculated continuously every 28 seconds.

Bland-Altman plot for Corsano SpO2 vs SaO2 co-oximetry reference — Clinical Validation: Bland-Altman correlation (98.8%, N=300) comparing CardioWatch SpO2 against arterial SaO2 in controlled hypoxia trials (CMC Europe, ISO 80601-2-61).

Cuffless Non-Invasive Blood Pressure (NIBP)

Continuous cuffless blood pressure estimation is driven by multi-channel PPG reflection waveforms analyzed by machine learning models. Features derived from time/frequency domains, derivative shapes, and vessel compliance enable continuous systolic and diastolic trend prediction without painful cuff inflation.

Systolic Range: 60 to 230 mmHg | Diastolic Range: 40 to 130 mmHg.
Clinical Accuracy: Mean error < 5 mmHg, Standard Deviation < 5 mmHg.
Regulatory Benchmark: Evaluated in accordance with ISO 81060-2:2019 standards across 97 clinical subjects.

Correlation chart between Corsano Cuffless NIBP and invasive blood pressure reference — CardioWatch Cuffless Blood Pressure prediction versus invasive arterial reference catheter measurements (Fysicon system).

Single-Lead Ambulatory Electrocardiogram (ECG)

The CardioWatch bracelet integrates a high-performance 1-lead ECG front-end with dry contacts (two back-casing electrodes on wrist skin and a top metal ring electrode for second-hand activation). Electromagnetic interference (EMI) filtering and Right-Leg Drive (RLD) circuit yield high signal-to-noise ratios.

Sampling Frequency: 256 Hz | Signal Range: ±1300 mV.
Frequency Bandwidth: 0.05 Hz to 55 Hz (Common-Mode Rejection Ratio >110 dB).
Safety & Performance Compliance: EN-IEC 60601-2-47:2015 accredited laboratory testing (Kiwa Dare, NL).

CardioWatch AFIB detection validation study data plot — Validation Data: AFIB screening results from RECAMO trial (NCT05899959) comparing PPG & ECG alerts against 24-hour Holter monitoring.

Core Body Temperature & Respiration Rate

Combining an internal GreenTEG heatflux sensor with PPG pulse dynamics allows non-invasive, self-calibrating Core Body Temperature (CBT) measurement. Meanwhile, proprietary time-frequency algorithms extract respiratory-induced amplitude and frequency variations (RIAV/RIFV) for breathing frequency.

Respiration Rate: 4 to 60 brpm (<3 brpm Arms overall accuracy).
Core Body Temp Range: 34.0°C to 42.0°C (0.1°C resolution, bias 0.14°C vs electronic pill reference).
Skin Temperature: ISO 80601-2-56 clinical thermometer standard compliant (VDE Institute tested).

Bland-Altman plot for Respiration Rate accuracy — Respiration Rate accuracy evaluation verified by Complementair Medisch Centrum Europe.

Performance Matrix

Verified Clinical Accuracy & Tolerance Summary

Summary performance metrics based on audited clinical protocol documentation (ISO 80601-2-61, ISO 81060-2, and ISO 80601-2-56).

Clinical Metric	Operational Range	Validated Accuracy (Arms)	Mean Bias
Pulse Rate	25 – 250 bpm	< 3 bpm Arms (Motion) / < 1 bpm (Rest)	< 0.5 bpm
Pulse Oximetry (SpO2)	70% – 100%	< 2% Arms (vs Arterial SaO2)	< 0.3%
Respiration Rate	4 – 60 brpm	< 3 brpm Arms (Supine < 1 brpm)	< 1.0 brpm
Cuffless Blood Pressure	60-230 mmHg (SYS) / 40-130 (DIA)	Mean Error < 5 mmHg (SD < 5 mmHg)	± 2.0 mmHg
Skin Temperature	30.0°C – 42.0°C	± 0.3°C (0.5°F)	N/A (Direct Probe)
Core Body Temperature	34.0°C – 42.0°C	Standard Deviation 0.34°C	0.14°C
Activity Steps	0 – 99,999 steps/day	< 2 steps Arms (RadboudMC study)	0.7 steps
AFIB Detection	0% – 100% probability	Sensitivity: 97.2% \| Specificity: 98.1% (ECG)	N/A
Sleep-Wake Efficiency	0% – 100% epoch scoring	97.0% overall accuracy vs Polysomnography	TST Bias: -0.5 min

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