Saranas Early Bird

JSON twin: https://www.healthaidb.com/software/saranas-early-bird.json

Company Name

Preventice Technologies

Product URL

https://www.preventice.com/products/saranas-early-bird-bleed-monitoring-system

Company URL

https://www.preventice.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

Saranas Early Bird is a medical device that enables real-time detection and monitoring of internal bleeding during endovascular procedures, enhancing patient safety and outcomes.

Description

Saranas Early Bird is the first FDA-approved device designed to detect and monitor bleeding complications during endovascular procedures. It integrates a bleed detection array with electrodes into a vascular access sheath, measuring bioimpedance changes to identify bleeding from vessel injury. Visual and audible indicators alert clinicians to the onset and progression of bleeding events, allowing for immediate intervention. This technology aims to reduce intra-procedural and post-procedural complications, shorten hospital stays, and lower healthcare costs. It is particularly beneficial in complex procedures like transcatheter aortic valve replacement (TAVR) and hemodynamic support device placement, where femoral artery or vein access is used. The device has been recognized with an Innovative Technology contract from Vizient and has been integrated into healthcare systems such as CommonSpirit Health and the Department of Defense. Additionally, Saranas has secured patents for integrating bleed monitoring with vascular access closure devices, further enhancing its clinical utility.

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23

Company Founding

2017

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10
• LOINC
• CPT
• NDC
• RxNorm
• ICD-9

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Real-time bleeding detection
• Continuous monitoring
• Automated alerts
• Data visualization
• Remote access
• Patient data integration
• Clinical decision support
• Customizable thresholds
• Wireless connectivity
• Battery backup
• User-friendly interface
• Data storage
• Event logging
• System diagnostics
• Software updates
• Remote troubleshooting
• Compliance reporting
• Data export
• Integration with hospital information systems
• Patient demographics tracking

Id

SW0349

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• LIS
• RIS
• EHR
• Pharmacy management systems
• Billing systems
• Patient monitoring devices
• Wearable health devices

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Advanced analytics
• Predictive modeling
• Integration with electronic health records (EHR)
• Integration with laboratory information systems (LIS)
• Integration with picture archiving and communication systems (PACS)
• Integration with radiology information systems (RIS)
• Integration with pharmacy management systems
• Integration with billing systems
• Integration with patient monitoring devices
• Integration with wearable health devices

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data residency options
• Data access controls
• Data retention policies
• Data breach notification
• Data subject rights management
• Data portability

Product Code

SW0349

Product Name

Saranas Early Bird

Ratings

Regions Available

• United States

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• TLS
• OAuth 2.0
• JWT
• API rate limiting

Specialties

• Cardiology
• Vascular Surgery
• Interventional Radiology

Support Channels

System Requirements

• Windows Server 2016 or later
• Linux (Ubuntu 18.04 or later)
• macOS Mojave or later
• iOS 12 or later
• Android 9 or later
• Web browser (Chrome, Firefox, Safari, Edge)

Target Users

• clinicians
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Saranas Early Bird",
  "company_name": "Preventice Technologies",
  "product_url": "https://www.preventice.com/products/saranas-early-bird-bleed-monitoring-system",
  "company_url": "https://www.preventice.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0349",
  "summary": "Saranas Early Bird is a medical device that enables real-time detection and monitoring of internal bleeding during endovascular procedures, enhancing patient safety and outcomes.",
  "description": "Saranas Early Bird is the first FDA-approved device designed to detect and monitor bleeding complications during endovascular procedures. It integrates a bleed detection array with electrodes into a vascular access sheath, measuring bioimpedance changes to identify bleeding from vessel injury. Visual and audible indicators alert clinicians to the onset and progression of bleeding events, allowing for immediate intervention. This technology aims to reduce intra-procedural and post-procedural complications, shorten hospital stays, and lower healthcare costs. It is particularly beneficial in complex procedures like transcatheter aortic valve replacement (TAVR) and hemodynamic support device placement, where femoral artery or vein access is used. The device has been recognized with an Innovative Technology contract from Vizient and has been integrated into healthcare systems such as CommonSpirit Health and the Department of Defense. Additionally, Saranas has secured patents for integrating bleed monitoring with vascular access closure devices, further enhancing its clinical utility.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients"
  ],
  "specialties": [
    "Cardiology",
    "Vascular Surgery",
    "Interventional Radiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Real-time bleeding detection",
    "Continuous monitoring",
    "Automated alerts",
    "Data visualization",
    "Remote access",
    "Patient data integration",
    "Clinical decision support",
    "Customizable thresholds",
    "Wireless connectivity",
    "Battery backup",
    "User-friendly interface",
    "Data storage",
    "Event logging",
    "System diagnostics",
    "Software updates",
    "Remote troubleshooting",
    "Compliance reporting",
    "Data export",
    "Integration with hospital information systems",
    "Patient demographics tracking"
  ],
  "optional_modules": [
    "Advanced analytics",
    "Predictive modeling",
    "Integration with electronic health records (EHR)",
    "Integration with laboratory information systems (LIS)",
    "Integration with picture archiving and communication systems (PACS)",
    "Integration with radiology information systems (RIS)",
    "Integration with pharmacy management systems",
    "Integration with billing systems",
    "Integration with patient monitoring devices",
    "Integration with wearable health devices"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "LIS",
    "RIS",
    "EHR",
    "Pharmacy management systems",
    "Billing systems",
    "Patient monitoring devices",
    "Wearable health devices"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CPT",
    "NDC",
    "RxNorm",
    "ICD-9"
  ],
  "api_available": "yes",
  "system_requirements": [
    "Windows Server 2016 or later",
    "Linux (Ubuntu 18.04 or later)",
    "macOS Mojave or later",
    "iOS 12 or later",
    "Android 9 or later",
    "Web browser (Chrome, Firefox, Safari, Edge)"
  ],
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "TLS",
    "OAuth 2.0",
    "JWT",
    "API rate limiting"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data residency options",
    "Data access controls",
    "Data retention policies",
    "Data breach notification",
    "Data subject rights management",
    "Data portability"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0349",
  "slug": "saranas-early-bird",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/saranas-early-bird.json"
  }
}