FDA issues emergency use authorization for COVID-19 predictive screening tool

CLEW announced this week that its COVID-19 predictive screening tool for use in ICUs has been issued an emergency use authorization by the U.S. Food and Drug Administration. 

According to the company, providers can use CLEW to help identify patients with a heightened chance of respiratory failure or hemodynamic instability – common COVID-19 complications. 

“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 [and] resource management,” said CLEW in a press statement.


Research has shown that severe respiratory failure related to interstitial pneumonia in both lungs is among the highest contributors to COVID-19 mortality rates. Early detection can allow for faster intervention and treatment, including via mechanical ventilation. It can also enable care teams to strategize about resource use – vital for capacity management.

According to the statement, the AI models for the CLEWICU tool were trained on nearly 100,000 ICU patients; they were developed for use in both local ICUs and TeleICUs. 

The tool also integrates workflow and resource decision-making for local and remote teams.

The CLEW tool is among several that have been issued FDA EUAs in response to the COVID-19 pandemic, including in vitro diagnostic tools, remote patient-monitoring devices, respiratory-assist devices and nonsurgical face masks. 

The CLEWICU tool is the only predictive screening device of its kind granted the authorization thus far.


Researchers have developed a number of AI-driven tools to try to aid in the detection of symptoms in COVID-19 patients.

In a study published in Nature Medicine last month, scientists at Mount Sinai Health System used AI in conjunction with imaging and clinical data to quickly diagnose patients with COVID-19. 

Vendors such as behold.ai, Thirona and Delft Imaging have also released software to quickly detect COVID-19 in patient X-rays using AI.

Meanwhile, modeling tools like those developed by Health Catalyst draw on existing patient data to predict hospital capacity and resources – a continuing concern throughout the country as rates rise again.


“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, in a statement.

“Healthcare providers need more than simple analytics. Systems need to integrate into the provider’s workflow, offering ease of use and actionable data,” he added. 


Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Healthcare IT News is a HIMSS Media publication.

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