FDA gives “emergency” approval to patient analytics tool

The new tool is already implemented in coronavirus units in two Israeli hospitals, and being tested by several US hospitals.
Jeff Rowe

As healthcare providers around the world continue to grapple with the effects of the COVID-19 pandemic, efforts are naturally also underway to anticipate and prepare for the distinct possibility of a second wave.

To that end, the FDA recently issued an Emergency Use Authorization for an AI-driven predictive analytics system from CLEW, a U.S-Israeli AI platform manufacturer, that is designed to proactively manage patient care and potential impacts on ICUs.

“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.”

According to the company, CLEW’s platform taps into clinical and patient data to deliver highly accurate predictive clinical analytics. CLEW’s analytics engine identifies relationships between real-time physiological data and latent medical conditions, recognizing – in real-time – any changes in the patient’s condition that may indicate the possibility of life-threatening situations. The platform utilizes innovative prediction models derived from Big Data analysis and advanced high-dimensional analytics, to provide hospital management and medical personnel with the preemptive information they require to better manage their resources.

The company said the AI models for the CLEW-ICU tool were trained on nearly 100,000 ICU patients and developed for use in both local ICUs and TeleICUs.  The tool also integrates workflow and resource decision-making for local and remote teams. With CLEW-ICU 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 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.

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.