We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Grants EUA for Dascena’s COVID-19 Machine Learning Algorithm

FDA Grants EUA for Dascena’s COVID-19 Machine Learning Algorithm

emergency use authorization approved
October 7, 2020

Dascena has obtained an Emergency Use Authorization (EUA) from the FDA for COViage, a machine learning algorithm that assists in the early detection of COVID-19 patients likely to experience symptoms such as low blood pressure or respiratory problems.

The algorithm works by analyzing patient data from electronic health records and gives healthcare providers advance notification of patients who are predicted to experience unstable blood pressure or a decline in respiratory function that requires mechanical ventilation. The EUA clears the software for use with adult patients by healthcare providers in hospitals.

“The early identification of patients at risk of respiratory decompensation or hemodynamic instability would enable physicians to more aggressively monitor these patients in a controlled environment and provide earlier treatment,” said Dascena’s CEO Ritankar Das.

View today's stories

Medical Devices COVID-19 Submissions and Approvals
  • Related Events

    Artificial Intelligence and Machine Learning in Medical Technology: Fundamentals and Emerging Regulations

Upcoming Events

  • 24Feb

    Virtual Site Training in Clinical Trials: The New Standard

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • WHO

    J&J Seeks WHO Emergency Use Listing for COVID-19 Vaccine

  • Partner Up, blocks

    Becton Dickinson, Scanwell Health Partnering on COVID-19 Rapid Home Test

  • AstraZeneca

    AstraZeneca Withdraws Imfinzi’s Bladder Cancer Indication

  • CE mark

    Cue Health’s COVID-19 Test Receives CE Mark

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing