CLEWICU System

JSON twin: https://www.healthaidb.com/software/clewicu-system.json

Company Name

Clew Medical

Product URL

https://www.clewmedical.com/clewicu-system

Company URL

https://www.clewmedical.com

Categories

• clinical Care
• diagnostic Support
• predictive Analytics
• remote Monitoring
• Clinical
• Diagnostic
• Patient Monitoring

Summary

CLEWICU System is an AI-driven solution that predicts hemodynamic instability in ICU patients up to eight hours in advance, enabling early intervention and optimized resource management.

Description

CLEWICU System by Clew Medical is an AI-based predictive analytics platform designed for intensive care units (ICUs). It continuously monitors patient data, including Electronic Health Records (EHR) and medical device information, to assess the risk of hemodynamic instability. The system provides clinicians with notifications up to eight hours before potential clinical deterioration, facilitating proactive patient care and efficient ICU resource allocation. CLEWICU has received FDA 510(k) clearance and Emergency Use Authorization (EUA) for its respiratory deterioration model, underscoring its regulatory compliance and effectiveness in critical care settings.

Api Available

yes

Certifications

• FDA 510(k) clearance
• CE mark
• ISO 13485 certification
• Registration with AMAR (Israeli Ministry of Health)

Company Founding

2014

Company Offices

• United States
• Israel
• European Union

Compliance

• HIPAA
• GDPR
• ISO 27001
• ISO 27799
• ISO 13485
• PCCP (FDA guidance alignment)

Customers

Data Residency

Israel, United States, European Union

Data Standards

• HL7 v2.x
• FHIR

Deployment Model

• SaaS
• cloud-hosted
• on_prem
• hybrid

Features

• Real-time patient data aggregation from EMR, ADT, and bedside devices
• Continuous high-fidelity data-stream analysis
• AI-driven predictive analytics for patient deterioration
• Configurable notifications and alerting
• Unit, hospital, and patient dashboards with risk visualization
• Surveillance and cohort-level monitoring
• Physician-in-the-loop model design and interpretability
• Data quality validation tools (real-time and offline)
• Configurable clinical workflows and views
• Bidirectional high-resolution audio/video for remote care
• Reporting and benchmarking for quality improvement
• Optional APACHE scores integration
• MLOps infrastructure for model lifecycle and regulatory readiness

Id

SW0265

Integration Partners

Integrations

• EMR/EHR systems (vendor-agnostic)
• ADT systems
• Patient biomedical monitors
• Life support devices
• SQL databases
• Custom interfaces
• Bidirectional AV/remote care systems

Languages Supported

• English
• Hebrew

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• Healthcare Institutions

Optional Modules

• APACHE scores integration
• Virtual ICU / TeleICU module
• Sepsis Virtual Unit
• Heart Failure Virtual Unit

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• HIPAA compliance
• GDPR compliance
• Real-time data quality validation

Product Code

SW0265

Product Name

CLEWICU System

Ratings

Regions Available

• United States
• European Union
• Israel

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Secure software development lifecycle (SSDLC)
• Third-party penetration testing
• HIPAA-compliant cloud environment
• ISO 27001-aligned security controls
• Encryption at the production cloud level

Specialties

• Intensive Care
• Critical Care
• Emergency Medicine

Support Channels

System Requirements

Target Users

• Clinicians
• ICU Staff
• Healthcare Administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "CLEWICU System",
  "company_name": "Clew Medical",
  "product_url": "https://www.clewmedical.com/clewicu-system",
  "company_url": "https://www.clewmedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0265",
  "summary": "CLEWICU System is an AI-driven solution that predicts hemodynamic instability in ICU patients up to eight hours in advance, enabling early intervention and optimized resource management.",
  "description": "CLEWICU System by Clew Medical is an AI-based predictive analytics platform designed for intensive care units (ICUs). It continuously monitors patient data, including Electronic Health Records (EHR) and medical device information, to assess the risk of hemodynamic instability. The system provides clinicians with notifications up to eight hours before potential clinical deterioration, facilitating proactive patient care and efficient ICU resource allocation. CLEWICU has received FDA 510(k) clearance and Emergency Use Authorization (EUA) for its respiratory deterioration model, underscoring its regulatory compliance and effectiveness in critical care settings.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "predictive Analytics",
    "remote Monitoring",
    "Clinical",
    "Diagnostic",
    "Predictive Analytics",
    "Patient Monitoring"
  ],
  "market_segment": [
    "Enterprise",
    "Healthcare Institutions"
  ],
  "target_users": [
    "Clinicians",
    "ICU Staff",
    "Healthcare Administrators"
  ],
  "specialties": [
    "Intensive Care",
    "Critical Care",
    "Emergency Medicine"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "Israel"
  ],
  "languages_supported": [
    "English",
    "Hebrew"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "Israel",
    "European Union"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "SaaS",
    "cloud-hosted",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Real-time patient data aggregation from EMR, ADT, and bedside devices",
    "Continuous high-fidelity data-stream analysis",
    "AI-driven predictive analytics for patient deterioration",
    "Configurable notifications and alerting",
    "Unit, hospital, and patient dashboards with risk visualization",
    "Surveillance and cohort-level monitoring",
    "Physician-in-the-loop model design and interpretability",
    "Data quality validation tools (real-time and offline)",
    "Configurable clinical workflows and views",
    "Bidirectional high-resolution audio/video for remote care",
    "Reporting and benchmarking for quality improvement",
    "Optional APACHE scores integration",
    "MLOps infrastructure for model lifecycle and regulatory readiness"
  ],
  "optional_modules": [
    "APACHE scores integration",
    "Virtual ICU / TeleICU module",
    "Sepsis Virtual Unit",
    "Heart Failure Virtual Unit"
  ],
  "integrations": [
    "EMR/EHR systems (vendor-agnostic)",
    "ADT systems",
    "Patient biomedical monitors",
    "Life support devices",
    "SQL databases",
    "Custom interfaces",
    "Bidirectional AV/remote care systems"
  ],
  "data_standards": [
    "HL7 v2.x",
    "FHIR"
  ],
  "api_available": "yes",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "ISO 27001",
    "ISO 27799",
    "ISO 13485",
    "PCCP (FDA guidance alignment)"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE mark",
    "ISO 13485 certification",
    "Registration with AMAR (Israeli Ministry of Health)"
  ],
  "security_features": [
    "Secure software development lifecycle (SSDLC)",
    "Third-party penetration testing",
    "HIPAA-compliant cloud environment",
    "ISO 27001-aligned security controls",
    "Encryption at the production cloud level"
  ],
  "privacy_features": [
    "HIPAA compliance",
    "GDPR compliance",
    "Real-time data quality validation"
  ],
  "data_residency": "Israel, United States, European Union",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0265",
  "slug": "clewicu-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/clewicu-system.json"
  }
}