Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.

AI algorithms trained on large retrospective dataset

Clew’s artificial intelligence-based algorithms were trained on 100,000 patients in ICUs to identify respiratory failure (RF) or hemodynamic instability (HI) hours before they occur, allowing patients to be evaluated further and started on an intervention, if needed. It easily can be scaled to handle surges in patient volume, while reducing the risk that clinicians will be exposed to COVID-19.

The EUA applies to the company’s ClewICUserver and ClewICUnitor. The server is a backend software platform that imports patient data from multiple sources, including electronic health records and medical device data, which is used to compute and store the ClewRF and ClewHI indexes. The ClewRF index is a measure of a patient’s predicted physiologic condition over a period of hours based the aggregate statistical risk of respiratory deterioration or failure. The ClewHI index indicates a patient’s physiologic condition based on the aggregate statistical risk of hemodynamic instability.

The ClewICUnitor is the front-end, web-based interface for displaying the ClewRF and ClewHI-related measures and notifications.

“Health care providers need more than simple analytics. Systems need to integrate into the provider’s workflow, offering ease of use and actionable date,” said Gal Salomon, Clew’s CEO. “The ClewICU platform is designed to enable health care 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 care.”

ClewICU is authorized for use in adults being treated for COVID-19 in the ICU to aid in the early identification of patients who are likely to be diagnosed with RF or HI. The FDA said there are no approved or cleared devices currently provide this function.

Clinical validation

The system’s performance was validated in a retrospective, multicenter study. For the RF intubation model, the sensitivity was 55.7%, with a positive predictive value (PPV) of 5.5% and median lead time for true positive alert of 3.4 hours. For the HI pressor model, sensitivity and PPV were 59.8% and 19%, respectively, with a median positive alert lead time of 3.5 hours.

The system is currently in use at Sheba Medical Center and Ichilov Hospital in Israel and is being assessed in prospective clinical trials in the U.S. via partnerships with the University of Massachusetts Memorial Medical Center and WakeMed Health and Hospitals in Raleigh, N.C., Salomon told BioWorld.

In addition to providing near real-time access to patient data, the streamlined, at-a-glance app facilitates workflow with worklist, unit and multiunit views, including unit occupancy and patient risk level. To facilitate decision-making, it also integrates local and remote caregiving teams.

Salomon cited anecdotal evidence that the platform not only provides better alerts and alarms, but also lets ICU teams know when patients are not going to deteriorate. That helps alleviate some of the burden on ICU doctors and nurses.

In January, Clew scooped up $10 million in a series B financing led by Pitango Venture Capital, bringing the startup’s total raised to about $20.5 million. The proceeds were earmarked to advance the ClewICU platform in the teleICU and critical care space.

“Things have progressed very well,” Salomon said. “We are progressing with the clinical studies, the FDA 510(k) review and product developments. For example, we are working on expanding the capabilities beyond the ICU into all care settings.”

출처: BioWorld