Israeli AI firm that offers early COVID-19 detection receives FDA approval

The Intensive Care Unit (ICU) solution was given Emergency Use Authorization (EUA) by the FDA, so that it may be implemented within the United States' health system as soon as possible.

By ZACHARY KEYSER
CLEW Predictive Analytics Platform in Support of COVID-19 Patients (photo credit: COURTESY OF CLEW)
CLEW Predictive Analytics Platform in Support of COVID-19 Patients
(photo credit: COURTESY OF CLEW)
CLEW, an Israeli medtech firm specializing in real-time AI analytics platforms, received approval from the United States Food and Drug Administration (FDA) for its "Predictive Analytics Platform in Support of COVID-19 Patients," the company announced Tuesday.
The Intensive Care Unit (ICU) solution was given Emergency Use Authorization (EUA) by the FDA so that it may be implemented within the United States' health system as soon as possible.
"CLEW, is officially the first and only AI powered device authorized by the FDA to provide early identification of respiratory failure and hemodynamic instability for COVID-19 patients," said managing general partner at Pitango Health, an investor in CLEW Ittai Harel. "CLEW's system was a key component in Covid-19 command centers in leading hospitals in Israel, and forward-looking, thrives to become an integral part of healthcare management worldwide, as we enter the 'new normal.'"
CLEW's AI analytics platforms assist health providers in making informed decisions regarding patient treatment, by  "predicting life-threatening complications across various medical care settings."
The COVID-19 platform runs a predictive screening process that helps identify patients who have "an increased likelihood" of falling ill to respiratory failure or hemodynamic instability - conditions linked to the novel coronavirus.
The new AI model, which uses an algorithm that incorporates information compiled from nearly 100,000 ICU patients, is able to provide early detection of these illnesses "hours in advance." This gives room for early intervention and additional assessment, while reducing the risk of exposure to doctors and nurses treating the patients.
“Healthcare providers need more than simple analytics. Systems need to integrate into the provider’s workflow, offering ease of use and actionable data," said CLEW CEO Gal Salomon. "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.”