cytovale-intellisep

JSON twin: https://www.healthaidb.com/software/cytovale-intellisep.json

Company Name

Cytovale

Product URL

https://cytovale.com/our-solution/intellisep-sepsis-test/

Company URL

https://cytovale.com

Categories

Summary

IntelliSep is an FDA-cleared, rapid in vitro diagnostic test that assesses host immune-cell biophysical changes to provide an actionable sepsis probability score in ~8–10 minutes for ED triage.

Description

IntelliSep (Cytovale) is a lab/point-of-care IVD run on the Cytovale System that uses microfluidics, deformability cytometry, high-resolution imaging and machine learning to analyze white blood cells from a small EDTA blood sample and produce a numerical sepsis probability (0.1–10.0) stratified into three risk bands to aid rapid diagnosis, risk stratification, and disposition in emergency departments and clinical laboratories. It is pathogen-agnostic, integrates results to the LIS, and is FDA 510(k) cleared for use in adults with signs or suspicion of infection.

Api Available

unknown

Certifications

Company Founding

2013

Company Offices

Compliance

Customers

Data Residency

Data Standards

Deployment Model

Features

Id

P0444

Integration Partners

Integrations

Languages Supported

Last Updated

2025-09-07

License

commercial/proprietary

Links

Market Segment

Optional Modules

Os Platforms

Pricing Details

contact vendor for pricing, implementation and service agreements

Pricing Model

enterprise_quote

Privacy Features

Ratings

Regions Available

Release Year

2023

Security Features

Specialties

Support Channels

System Requirements

Cytovale System hardware; 100 µL K2 EDTA blood tube (ED triage/lab integration)

Target Users

Training Options

Type

product

User Reviews

Version

1.0

Canonical JSON

{
  "company_name": "Cytovale",
  "company_url": "https://cytovale.com",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2013",
  "product_url": "https://cytovale.com/our-solution/intellisep-sepsis-test/",
  "categories": [
    "diagnostic",
    "clinical",
    "laboratory",
    "emergency department",
    "host response diagnostics"
  ],
  "market_segment": [
    "enterprise",
    "hospital"
  ],
  "links": [
    "https://cytovale.com",
    "https://cytovale.com/our-solution/intellisep-sepsis-test/",
    "https://cytovale.com/our-solution/our-science/",
    "https://cytovale.com/support/contact-information/",
    "https://cytovale.com/about/news-and-events/",
    "https://pubmed.ncbi.nlm.nih.gov/38643433/",
    "https://medicalcountermeasures.gov/barda/sepsis/",
    "https://www.linkedin.com/company/cytovale",
    "https://cytovale.com/our-solution/real-world-impact/"
  ],
  "summary": "IntelliSep is an FDA-cleared, rapid in vitro diagnostic test that assesses host immune-cell biophysical changes to provide an actionable sepsis probability score in ~8–10 minutes for ED triage.",
  "description": "IntelliSep (Cytovale) is a lab/point-of-care IVD run on the Cytovale System that uses microfluidics, deformability cytometry, high-resolution imaging and machine learning to analyze white blood cells from a small EDTA blood sample and produce a numerical sepsis probability (0.1–10.0) stratified into three risk bands to aid rapid diagnosis, risk stratification, and disposition in emergency departments and clinical laboratories. It is pathogen-agnostic, integrates results to the LIS, and is FDA 510(k) cleared for use in adults with signs or suspicion of infection.",
  "target_users": [
    "emergency physicians",
    "ED nurses",
    "laboratory technologists",
    "hospitalists",
    "clinical laboratory directors",
    "hospital administrators"
  ],
  "specialties": [
    "emergency medicine",
    "critical care",
    "infectious diseases",
    "laboratory medicine",
    "internal medicine"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "contact vendor for pricing, implementation and service agreements",
  "license": "commercial/proprietary",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "proprietary instrument software (Cytovale System)"
  ],
  "features": [
    "rapid ~8 minute blood-to-score test",
    "host-response (white blood cell biophysical) analysis",
    "microfluidics and deformability cytometry",
    "high-resolution cell imaging",
    "machine learning–based scoring",
    "numerical probability score (0.1–10.0) with 3 risk bands",
    "fits ED and laboratory workflows",
    "uses 100 µL from K2 EDTA tube",
    "automated result delivery to LIS",
    "risk stratification for sepsis triage"
  ],
  "optional_modules": [],
  "integrations": [
    "Laboratory Information System (LIS)"
  ],
  "data_standards": [
    "HL7 v2"
  ],
  "api_available": "unknown",
  "system_requirements": "Cytovale System hardware; 100 µL K2 EDTA blood tube (ED triage/lab integration)",
  "compliance": [
    "FDA 510(k)"
  ],
  "certifications": [
    "FDA 510(k) clearance"
  ],
  "security_features": [],
  "privacy_features": [],
  "data_residency": "",
  "customers": [
    "Our Lady of the Lake Regional Medical Center (Our Lady of the Lake Health)",
    "Our Lady of the Lake Health System",
    "Our Lady of the Lake Regional Medical Center (Baton Rouge)",
    "LSU Health (partner sites reported in studies)"
  ],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [
    "email",
    "phone"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite"
  ],
  "release_year": "2023",
  "integration_partners": [
    "STRATEC",
    "Laboratory Information Systems (LIS) integrations",
    "Hospital implementation partners (Our Lady of the Lake Health)"
  ],
  "id": "P0444",
  "slug": "cytovale-intellisep",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-09-07",
  "links_json": {
    "self": "https://www.healthaidb.com/software/cytovale-intellisep.json"
  }
}