Accelerate Pheno System

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

Company Name

Accelerate Diagnostics

Product URL

https://www.acceleratediagnostics.com/products/accelerate-pheno-system

Company URL

https://www.acceleratediagnostics.com

Categories

• diagnostic Support
• clinical Care
• laboratory Testing
• infectious Diseases
• Diagnostic
• Clinical
• Laboratory
• Infectious Disease
• Antibiotic Susceptibility Testing

Summary

The Accelerate Pheno System is an in vitro diagnostic platform that rapidly identifies infectious pathogens and determines their antibiotic susceptibility directly from positive blood cultures, enabling clinicians to make timely, informed treatment decisions.

Description

The Accelerate Pheno System automates sample preparation, pathogen identification, and antibiotic susceptibility testing, delivering results in approximately seven hours. This rapid turnaround allows clinicians to optimize antibiotic therapy for patients with serious infections, such as sepsis, more quickly than traditional methods, which can take 1–2 days longer. The system comprises a fixed instrument and single-use test kits, streamlining laboratory workflows and improving patient outcomes by facilitating prompt, targeted treatment decisions.

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• ISO 9001
• ISO 27001
• SOC 2
• ISO 15189
• ISO 15190
• ISO 22870
• ISO 15197
• ISO 15193
• ISO 15194
• ISO 15195
• ISO 15196

Company Founding

2004

Company Offices

• United States
• Germany

Compliance

• HIPAA
• FDA 510(k)
• CLIA
• ISO 13485
• CE Mark
• ISO 14971
• ISO 9001
• ISO 27001
• SOC 2
• GDPR
• HITECH
• FDA 21 CFR Part 11
• ISO 15189
• ISO 15190
• ISO 22870
• ISO 15197
• ISO 15193
• ISO 15194
• ISO 15195
• ISO 15196

Customers

Data Residency

US-only

Data Standards

• HL7 v2
• FHIR
• DICOM
• SNOMED CT
• ICD-10
• LOINC
• CPT
• MIMIC-III
• ICD-9
• NDC

Deployment Model

• on_prem

Features

• Rapid antimicrobial susceptibility testing
• Comprehensive pathogen identification
• Real-time results reporting
• User-friendly interface
• Automated workflow integration
• High-throughput processing
• Minimal hands-on time
• Reduced time to result
• Enhanced clinical decision support
• Cost-effective testing solution
• Compact benchtop design
• Scalable throughput options
• Comprehensive assay menu
• Quality control integration
• Regulatory compliance support
• Data management capabilities
• Remote monitoring and support
• Software updates and maintenance
• Training and support services
• Clinical validation studies

Id

SW0497

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• Billing systems
• Laboratory information management systems (LIMS)
• Automated sample handling systems
• Clinical decision support systems (CDSS)
• Inventory management systems
• Quality control software
• Data analytics platforms
• Cloud storage services
• Remote monitoring tools
• Maintenance management systems
• Training platforms
• Regulatory compliance tools
• Patient management systems
• Order entry systems
• Specimen tracking systems
• Clinical trial management systems
• Research databases

Languages Supported

• English
• German
• Arabic

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise

Optional Modules

• Advanced data analytics
• Integration with electronic health records (EHR)
• Cloud-based data storage
• Customizable reporting templates
• Barcode scanning integration
• Sample tracking system
• Automated reagent management
• Maintenance scheduling tools
• Quality assurance modules
• Regulatory reporting tools

Os Platforms

• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent management
• Data anonymization
• Data minimization
• Data retention policies
• Access controls
• Data masking
• Secure data storage
• Data access auditing
• Data sharing policies

Product Code

SW0497

Product Name

Accelerate Pheno System

Ratings

Regions Available

• United States
• Europe
• Middle East

Related Urls

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

Release Year

Security Features

• Data encryption at rest and in transit
• Role-based access control (RBAC)
• Single sign-on (SSO)
• Audit logs
• Two-factor authentication (2FA)
• Data loss prevention (DLP)
• Network segmentation
• Regular security updates
• Intrusion detection systems (IDS)
• Firewall protection

Specialties

• Infectious Diseases
• Sepsis
• Antimicrobial Stewardship

Support Channels

System Requirements

Windows Server 2016 or later, Linux (Ubuntu 18.04 or later), 16 GB RAM, 500 GB SSD storage, 1 Gbps Ethernet connection

Target Users

• clinicians
• laboratory technicians
• infectious disease specialists
• hospital microbiology laboratories

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Accelerate Diagnostics",
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  "company_url": "https://www.acceleratediagnostics.com",
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  "product_code": "SW0497",
  "summary": "The Accelerate Pheno System is an in vitro diagnostic platform that rapidly identifies infectious pathogens and determines their antibiotic susceptibility directly from positive blood cultures, enabling clinicians to make timely, informed treatment decisions.",
  "description": "The Accelerate Pheno System automates sample preparation, pathogen identification, and antibiotic susceptibility testing, delivering results in approximately seven hours. This rapid turnaround allows clinicians to optimize antibiotic therapy for patients with serious infections, such as sepsis, more quickly than traditional methods, which can take 1–2 days longer. The system comprises a fixed instrument and single-use test kits, streamlining laboratory workflows and improving patient outcomes by facilitating prompt, targeted treatment decisions.",
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  "target_users": [
    "clinicians",
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  "specialties": [
    "Infectious Diseases",
    "Sepsis",
    "Antimicrobial Stewardship"
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  "regions_available": [
    "United States",
    "Europe",
    "Middle East"
  ],
  "languages_supported": [
    "English",
    "German",
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  "pricing_model": "subscription",
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  "license": "commercial",
  "company_offices": [
    "United States",
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  "company_founding": "2004",
  "deployment_model": [
    "on_prem"
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  "os_platforms": [
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  "features": [
    "Rapid antimicrobial susceptibility testing",
    "Comprehensive pathogen identification",
    "Real-time results reporting",
    "User-friendly interface",
    "Automated workflow integration",
    "High-throughput processing",
    "Minimal hands-on time",
    "Reduced time to result",
    "Enhanced clinical decision support",
    "Cost-effective testing solution",
    "Compact benchtop design",
    "Scalable throughput options",
    "Comprehensive assay menu",
    "Quality control integration",
    "Regulatory compliance support",
    "Data management capabilities",
    "Remote monitoring and support",
    "Software updates and maintenance",
    "Training and support services",
    "Clinical validation studies"
  ],
  "optional_modules": [
    "Advanced data analytics",
    "Integration with electronic health records (EHR)",
    "Cloud-based data storage",
    "Customizable reporting templates",
    "Barcode scanning integration",
    "Sample tracking system",
    "Automated reagent management",
    "Maintenance scheduling tools",
    "Quality assurance modules",
    "Regulatory reporting tools"
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  "integrations": [
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    "Cerner",
    "PACS",
    "Billing systems",
    "Laboratory information management systems (LIMS)",
    "Automated sample handling systems",
    "Clinical decision support systems (CDSS)",
    "Inventory management systems",
    "Quality control software",
    "Data analytics platforms",
    "Cloud storage services",
    "Remote monitoring tools",
    "Maintenance management systems",
    "Training platforms",
    "Regulatory compliance tools",
    "Patient management systems",
    "Order entry systems",
    "Specimen tracking systems",
    "Clinical trial management systems",
    "Research databases"
  ],
  "data_standards": [
    "HL7 v2",
    "FHIR",
    "DICOM",
    "SNOMED CT",
    "ICD-10",
    "LOINC",
    "CPT",
    "MIMIC-III",
    "ICD-9",
    "NDC"
  ],
  "api_available": "yes",
  "system_requirements": "Windows Server 2016 or later, Linux (Ubuntu 18.04 or later), 16 GB RAM, 500 GB SSD storage, 1 Gbps Ethernet connection",
  "compliance": [
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    "FDA 510(k)",
    "CLIA",
    "ISO 13485",
    "CE Mark",
    "ISO 14971",
    "ISO 9001",
    "ISO 27001",
    "SOC 2",
    "GDPR",
    "HITECH",
    "FDA 21 CFR Part 11",
    "ISO 15189",
    "ISO 15190",
    "ISO 22870",
    "ISO 15197",
    "ISO 15193",
    "ISO 15194",
    "ISO 15195",
    "ISO 15196"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "ISO 9001",
    "ISO 27001",
    "SOC 2",
    "ISO 15189",
    "ISO 15190",
    "ISO 22870",
    "ISO 15197",
    "ISO 15193",
    "ISO 15194",
    "ISO 15195",
    "ISO 15196"
  ],
  "security_features": [
    "Data encryption at rest and in transit",
    "Role-based access control (RBAC)",
    "Single sign-on (SSO)",
    "Audit logs",
    "Two-factor authentication (2FA)",
    "Data loss prevention (DLP)",
    "Network segmentation",
    "Regular security updates",
    "Intrusion detection systems (IDS)",
    "Firewall protection"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Consent management",
    "Data anonymization",
    "Data minimization",
    "Data retention policies",
    "Access controls",
    "Data masking",
    "Secure data storage",
    "Data access auditing",
    "Data sharing policies"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
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  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
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