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CLEW Receives FDA Emergency Use Authorization (EUA) for its Predictive Analytics Platform in Support of COVID-19 Patients

CLEWICU is the only device authorized by the FDA to provide early identification of patients who are likely to experience respiratory failure or hemodynamic instability, both potentially common but significant complications associated with COVID-19

CLEW  announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company’s ICU solution. With CLEWICU healthcare providers use predictive screening information to help identify patients with an increased likelihood of being diagnosed with respiratory failure or hemodynamic instability which are common complications associated with COVID-19.

      • The AI-based algorithms are machine-learning models trained to identify respiratory failure and or hemodynamic instability hours in advance. This allows for additional evaluation and potentially early intervention, planning, resource management.
      • CLEW’s AI models were trained on nearly 100,000 patients in the ICUs, and scales to cope with patient volume surges while reducing a caregiver’s exposure risk to infected patients.
      • CLEW’s models were developed and intended for both local ICUs and TeleICUs and integrates best practice modules.
      • The streamlined at-a-glance web application is designed for near real-time access to patient data and provides tools for both worklist, unit and multiunit views, featuring unit occupancy and patient risk level.
      • CLEW-ICU integrates caregiving of local and remote teams enabling workflow and resource decision making.

“Healthcare providers need more than simple analytics. Systems need to integrate into the provider’s workflow, offering ease of use and actionable data. The CLEWICU platform is designed to enable healthcare providers to monitor patient predicted risk levels across all units in real-time allowing for smart decision making about clinical resource allocation, ensuring prompt, proactive and efficient patient care” said Gal Salomon, CLEW CEO.

Patient View
Rapid, clear, consistent patient data summary and visualization

  • Patient risk stratification (high, moderate and low risk patients)
  • Intubated patients
  • Vasopressors/inotrope support
  • Empty beds
  • Key patient and unit information
  • Occupancy, ventilator status and vasoactive medication
  • User selectable vital sign display
  • Summary of all relevant lab results
    Dynamic and collaborative caregiver task list
  • Aggregate patient demographicsand PMH (past medical history) andpredicted risk level

Patient View
Rapid, clear, consistent patient data summary and visualization
High Risk Patients

  • Tasks
  • New Admissions (pulled from a left sidebar)
  • User selectable vital sign display
  • Summary of all relevant lab results
  • Dynamic and collaborative caregiver task list
  • Aggregate patient demographics, PMH and risk level

Unit View
Full TeleICU situational awareness, displaying patient data and predicted state from all units and highlighting all notifications

  • Patient risk stratification (high, moderate and low risk patients)
    Intubated patients
  • Patients on vasoactive medication
    Unit occupancy
  • Patients on vasoactive medication
  • High-level estimation of the overall unit acuity

    Key patient and unit information

     

Work List
Integration with the TeleICU workflow by gathering all notifications, tasks, new admissions and high-risk patients

  • Notifications
  • High Risk Patients
  • Tasks
  • New Admissions (pulled from a left sidebar)

Unit View by Layout

Full ICU situational awareness, displaying patient data and predicted risk level, for one unit or multiple units. The display highlights all notifications, low risk patients and other key clinical information, to provide multi-dimensional situational awareness.

  • Patient risk stratification (high, moderate and low risk patients))
  • Intubated patients
  • Vasopressors/inotrope support
  • Empty beds
  • Key patient and unit information
  • Occupancy, ventilator status and vasoactive medication
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