CLEW Receives FDA Emergency Use Authorization 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

TEL AVIV, Israel and WILMINGTON, Delaware -- 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.

U.S. Media Contacts:

MItch Steiner 

Cheryl Isen 

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CLEW provides real-time AI analytics platforms designed to help providers make better informed clinical decisions by predicting life-threatening complications across various medical care settings. CLEW's goal is to provide solutions that could improve outcomes and safety, streamline patient care, and efficiently handle regulations and penalties, ultimately lowering the cost of care. Originally developed and proven in the ICU, CLEW will develop machine learning models that have the potential to optimize clinical resources and guide health care providers in predicting patient deterioration, across all care settings