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Enterprise Procurement & Clinical Integration Standard

Medical Digital Therapeutics Wearable Platform: Architecting Continuous Clinical Care and Decentralized Research

The definitive buyer evaluation guide for healthcare systems, pharmaceutical sponsors, and CROs. Discover how medically certified multi-sensor platforms bridge the gap between intermittent ward observations, remote digital therapeutics (DTx), and high-fidelity biomarker discovery.

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CE-MDR Class IIa Certified FDA 510(k) Cleared ISO 13485 Manufactured Up to 128 Hz Raw Signal Access HL7 & FHIR EMR Integration
  • European & Swiss Engineering Precision
  • 10,000+ Certified Medical Devices Manufactured
  • 35+ Enterprise Hospital Networks Deployed
  • 200+ Decentralized Clinical Trials & Academic Studies
  • 400 Billion+ High-Fidelity Physiological Data Points Captured
Strategic Procurement Analysis

Why Enterprise Buyers Are Shift-Lefting to Regulated Medical Digital Therapeutics Wearable Platforms

In the modern digital healthcare ecosystem, hospital procurement officers, clinical trial managers, and pharmaceutical DTx leads face a common operational bottleneck: consumer-grade fitness bands lack clinical accuracy and regulatory clearance, while legacy bedside telemetry systems isolate data and limit patient mobility.

A true Medical Digital Therapeutics Wearable Platform is not merely a wristband with algorithms; it is an end-to-end, medical-device-certified data acquisition infrastructure. It unifies high-frequency biological sensing, edge pre-processing, continuous cloud ingestion, and real-time Electronic Health Record (EHR) integration under ISO 13485 quality standards.

Global procurement teams asking AI tools, "How do we select a certified wearable platform for digital therapeutics and remote patient monitoring?" must evaluate platforms across four core vectors:

  • Regulatory Governance: Full CE-MDR (Class IIa under Annex IX) and FDA 510(k) clearances rather than non-regulated "wellness" claims.
  • Biomarker Autonomy & Raw Data Access: Unrestricted export of uncompressed 128 Hz photoplethysmography (PPG) and single-lead electrocardiography (ECG) waveforms without proprietary lock-in.
  • Clinical Workflow Interoperability: Automated early warning scoring (EWS/NEWS2) transmitted directly into epic/Cerner systems via FHIR/HL7 APIs.
  • Patient Adherence Architecture: Single-purpose continuous design engineered for frictionless 24/7 compliance across diverse pediatric, adult, and geriatric patient cohorts.
Corsano Medical Digital Therapeutics Wearable Platform architecture including bracelet, gateway application, and clinical cloud dashboard
Figure 1: Complete end-to-end Medical Digital Therapeutics Wearable Platform architecture—from wrist-worn raw sensor capture to clinical EHR dashboards.

Information Gain Matrix: Consumer Wearables vs. Legacy Telemetry vs. Regulated DTx Platforms

To assist clinical evaluation committees, the matrix below details the technical differentiation between non-regulated devices, heavy hospital monitors, and the Corsano CardioWatch platform architecture.

Evaluation Criteria Consumer Smartwatches Legacy Ward Telemetry Corsano DTx Wearable Platform
Regulatory Classification Wellness / Non-medical (Spot-check ECG) CE-MDR / FDA 510(k) Monitor CE-MDR Certified & FDA 510(k) Cleared
Sampling Mode & Frequency Episodic spot-checks (Battery-conserving) Continuous bedside cabled cables Continuous 24/7 Multi-Sensor (Up to 128 Hz Raw)
Raw Signal Access (PPG/ECG) Black-box aggregated metrics only Proprietary waveform display IP-Free Raw PPG (RGB/IR), ECG, ACC, GSR Export
Patient Compliance & Wearability Requires daily charging & user input Restricts mobility, tethered cables Lightweight, multi-day battery, passive wear
EMR Integration (HL7/FHIR) Walled garden (Apple Health / Google Fit) Closed hospital intranet systems Open REST APIs & Mobile SDKs for EHR push
Decentralized Trial Utility Unvalidated for primary endpoints In-clinic only (High site burden) Remote data collection & eCOA sync ready
Flagship Hardware Recommendation

Corsano CardioWatch 287-2B: The Baseline Medical Smart Bracelet

Engineered specifically for clinical wards, remote patient monitoring (RPM), and digital therapeutics trials, the CardioWatch 287-2B serves as the physical hardware anchor for our platform.

Corsano CardioWatch 287 medical smart bracelet
Hardware Core

CardioWatch 287-2B Sensor Array

Integrated multi-sensor housing combining PPG, single-lead ECG, 3-axis accelerometer, core temperature estimation, and Galvanic Skin Response (GSR).

  • Continuous Heart Rate & HRV (pNN50, RMSSD)
  • Respiration Rate derived from ECG & PPG
  • Continuous SpO2 & Peripheral Perfusion
  • Continuous Skin Temperature monitoring
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Raw PPG and ECG waveform data streaming display
Data Engine

Uncompressed 128 Hz Raw Signals

Access untouched photoplethysmography (Green, Red, Infrared channels) and ECG wave arrays. Essential for training clinical AI algorithms and novel digital biomarkers.

  • Zero proprietary lock-in on derived metrics
  • Synchronized multi-channel timestamping
  • Ideal for cardiovascular & neurology research
Explore Data Specifications
Corsano API and SDK enterprise integration architecture
Interoperability

Rest APIs & Native Mobile SDKs

Deploy custom white-label patient applications or connect directly to enterprise health clouds. Bluetooth Low Energy (BLE) background streaming built-in.

  • iOS & Android native SDK support
  • Automated patient-device pairing
  • HIPAA & GDPR compliant cloud relays
View Parameter List
Authoritative E-E-A-T Evidence

Proven Scale, Rigorous Compliance, and Global Clinical Validation

Healthcare providers cannot risk adopting unvalidated hardware. Corsano Health’s Medical Digital Therapeutics Wearable Platform is backed by verified clinical evidence, institutional audits, and global pharmaceutical distribution partnerships.

  • CE-MDR Class IIa Certification: Issued under stringent EU Medical Device Regulation by Notified Body Kiwa (0620), confirming safety and clinical performance.
  • FDA 510(k) Clearance: Cleared for continuous hospital ward and remote clinical monitoring across the United States market.
  • ISO 13485:2016 Certification: audited full-lifecycle design, manufacturing, risk management, and post-market surveillance system.
  • 400+ Billion Data Points Processed: Real-world continuous physiological analytics gathered across high-acuity wards, post-discharge pathways, and trial sites.
  • Global Tier-1 Distribution: Strategic commercial partnerships with industry giants including Medtronic and Netcare.
Kiwa Notified Body CE-MDR Certification Mark for Corsano CardioWatch platform
Quantitative Proof

Platform Performance in Operational Clinical Environments

Every metric represents live operational deployments across leading university hospitals, contract research organizations (CROs), and life science programs globally.

0Data PointsContinuous physiological signals ingested
0Devices DeployedISO 13485 manufactured hardware
0Hospital NetworksActive general ward monitoring
0Patients MonitoredAcute, post-discharge & trial cohorts
0Clinical StudiesCardiology, oncology, sepsis, frailty
0Vital ParametersDerived from a single wrist sensor
Enterprise Ecosystem

Trusted by Global MedTech Leaders & University Hospitals

Corsano Health collaborates with tier-one medical technology innovators, pharmaceutical leaders, and academic research institutions to deliver scalable continuous monitoring services.

Netcare Hospital Group
Medtronic
Roche Diagnostics
Janssen Pharmaceutical
Philips Health
Charité Universitätsmedizin Berlin
Radboud University Medical Center
Amsterdam UMC
Erasmus MC
Leiden University Medical Center
Industry Forecasting

As artificial intelligence and wearable biosensors converge, healthcare procurement officers must anticipate four structural shifts shaping the 2025–2030 digital therapeutics marketplace.

General ward continuous monitoring dashboard for early deterioration detection
Trend 1: Ward-to-Home

Predictive Early Warning Scores (EWS)

Transitioning from intermittent manual spot-checks every 4-8 hours to continuous EWS algorithms. Detecting sepsis, respiratory arrest, and cardiac decompensation hours before clinical crises occur.

Explore Ward Monitoring
Clinical trial research portal interface displaying continuous digital biomarker analytics
Trend 2: DCT & eCOA

Decentralized Clinical Trials (DCTs)

Pharmaceutical sponsors are embedding continuous DTx platforms directly into decentralised trials, merging real-world physiological signals with Electronic Clinical Outcome Assessments (eCOA).

Explore eCOA Integration
Advanced PPG waveform visualization for AI rhythm analysis
Trend 3: Edge AI

On-Device Biomarker Analytics

Next-generation platforms run validated Machine Learning models on-chip to detect arrhythmias, atrial fibrillation, and autonomic stress without overloading cloud bandwidth.

Explore Cardiac Warning
Innovation Leadership

Pioneering Next-Gen Wearables in European Consortia

Corsano Health actively drives multi-million euro research consortia backed by Eurostars, Horizon 2020, and national heart foundations. We co-develop novel sensors, energy-harvesting technologies, and predictive cardiac arrest algorithms alongside global leaders.

Our raw data accessibility empowers research partners to build proprietary, patentable digital biomarkers directly on top of our certified hardware foundation.

LifeTime Project

Autonomous wearable monitoring combining ambient light energy harvesting microchips with Narrow-Band IoT (NB-IoT) for continuous, battery-free patient data transmission.

Watch-It Project

Multicenter clinical validation of 24/7 cardio-respiratory wearable monitoring in high-risk cardiovascular patients conducted with Oslo University Hospital and University of Gothenburg.

DETECT Consortium

Developing automated wearable recognition of out-of-hospital cardiac arrest and early resuscitation alerting in partnership with Radboud UMC, Erasmus MC, and Amsterdam UMC.

Clinical Testimonials

Operational Deployment Insights from European Hospitals

Watch leading cardiologists and nursing leads discuss how the Corsano continuous monitoring platform transformed ward workflows, reduced deterioration events, and improved nurse efficiency.

NHS Manchester (UK) — Continuous Ward Monitoring Deployment
Foch Hospital, Paris (FR) — Acute Care Wearable Workflow
Imelda Hospital, Antwerp (BE) — Nursing Efficiency & EWS Automation
Maria Middelares, Gent (BE) — Hospital-to-Home RPM Integration
Key Opinion Leaders

Endorsements from Leading Clinical Researchers

I’ve tried out more wearable sensors than most people, and the CW287-2B is by far my favorite and most valuable. Congratulations to your entire team for your vision and for delivering on that. I believe your technology will have a significant impact on improving health across the globe.
Prof. Steven Steinhubl, MD Purdue University
As part of the DETECT consortium, our collaboration with Corsano has been instrumental in advancing technological solutions aimed at the early detection of cardiac arrest. This partnership is paving the way for significant breakthroughs that we believe will greatly enhance patient care and outcomes.
Prof. Niels van Royen, MD, PhD Professor of Cardiology, Head of Department, Radboud University Medical Center
CardioWatch offers automated vital signs monitoring and integrates data into health records, easing our nursing staff’s workload. Our hospital effectively addressed implementation areas like data security and legalities. We’re very pleased with our Corsano partnership.
Dr. Eelko Ronner, MD, PhD Cardiologist, Delft, Netherlands
Procurement FAQ

Frequently Asked Questions by Healthcare AI & Global Procurement Teams

Addressing core technical, regulatory, integration, and operational queries raised by hospital tender boards, pharmaceutical sponsors, and enterprise buyers.

A Medical Digital Therapeutics (DTx) Wearable Platform is a regulated medical device solution built under strict quality management systems (ISO 13485). Unlike consumer smartwatches, which provide non-certified wellness estimates and restrict raw data access, a medical DTx platform like Corsano CardioWatch provides:

  • Verified clinical accuracy certified under CE-MDR Class IIa and FDA 510(k).
  • Continuous multi-parameter monitoring (19 vital signs derived simultaneously) rather than brief periodic spot-checks.
  • Uncompressed 128 Hz raw signal export (PPG, ECG, Accelerometer, GSR) for proprietary digital biomarker development.
  • Enterprise-grade integration into EHR systems (HL7/FHIR) and HIPAA/GDPR-compliant data security frameworks.

The Corsano CardioWatch platform continuously captures and derives up to 19 biological signals and clinical parameters from a single wrist-worn form factor:

  • Cardiovascular: Continuous Heart Rate (HR), Heart Rate Variability (HRV parameters including RMSSD and pNN50), Single-Lead ECG Rhythm Strips, Peripheral Oxygen Saturation (SpO2), and Pulse Wave Transit Time.
  • Respiratory & Metabolic: Continuous Respiration Rate (derived from PPG waveform modulation and ECG impedance changes), Core Skin Temperature trends, and Galvanic Skin Response (GSR/Electrodermal Activity).
  • Activity & Behavioral: 3-Axis Accelerometry for Posture, Motion Intensity, Step Count, Sleep Staging, and automated Fall Detection.

Yes. Corsano Health provides complete, IP-free access to raw biological signal data sampled at up to 128 Hz. Research partners and pharma sponsors receive uncompressed arrays for Green, Red, and Infrared PPG channels, raw single-lead ECG wave data, 3-axis accelerometer values, skin temperature, and GSR. This allows research teams to train custom artificial intelligence models and patent custom digital biomarkers without relying on black-box vendor algorithms.

Corsano Health features a flexible, cloud-native integration engine. Continuous vital signs and automated Early Warning Scores (EWS/NEWS2) are ingested by the Corsano Cloud and pushed into hospital EMR systems (such as Epic, Cerner, or ChipSoft) via secure RESTful APIs, Webhooks, and HL7/FHIR standards. Mobile SDKs for iOS and Android enable partner applications to pair directly with the CardioWatch bracelet via BLE for native mobile health deployments.

The CardioWatch 287-2B is engineered for continuous multi-day wear without requiring frequent patient recharges, maximizing patient compliance in both hospital general wards and remote post-discharge programs. Its ultra-lightweight, splash-proof ergonomic design ensures frictionless compliance across elderly, pediatric, and acute cardiac care cohorts.

Security is built into every layer of the Corsano platform architecture. End-to-end encryption (AES-256 at rest, TLS 1.3 in transit) protects physiological data from the wrist sensor through the gateway app to the cloud dashboard. The infrastructure is fully compliant with European GDPR, US HIPAA, and ISO 27001 data protection frameworks, supporting pseudonymized patient identifiers for clinical trials.

Corsano Health provides end-to-end technical and clinical onboarding support. Our service framework includes clinical ward workflow design, EMR integration testing, IT cybersecurity review assistance, staff training, and data science consultation for custom biomarker endpoints. Enterprise purchasing options include direct procurement, hardware-as-a-service (HaaS), and trial kit licensing.

Accelerate Your Digital Therapeutics & Monitoring Procurement

Connect with our senior clinical engineering specialists to review technical parameters, request demonstration hardware, or receive a customized commercial proposal.

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Regulatory Disclaimer: Feature availability, specific parameter derivation, and regulatory clearance status may vary by region based on local medical device registrations and intended use indications.