Israeli medical analytics startup Clew Medical announced this week that it received 510(k) clearance and authorization from the US FDA for the use of the Clew-ICU, the company’s artificial intelligence-based ICU solution, to predict hemodynamic (blood flow) instability in adult patients.
The clearance is the FDA’s first for such a device and follows the FDA’s Emergency Use Authorization (EUA) for Clew’s respiratory deterioration model granted in June 2020 for the predictive screening of COVID-19 and other ICU patients.
Founded in 2014, Clew develops real-time AI analytics platforms designed to help providers make better-informed clinical decisions by predicting life-threatening medical complications. Clew’s platform adjusts to cope with patient volume surges, reducing a caregiver’s exposure risk to infected patients, according to the company.
Clew-ICU monitors and categorizes patient risk levels, providing clinicians with physiological insight into a patient’s likelihood of future hemodynamic instability, the company says. The system provides notification of clinical deterioration up to eight hours in advance, enabling early evaluation and subsequent intervention for prompt, proactive patient care.
The system also identifies low-risk patients who are unlikely to deteriorate, thus enabling better ICU resource management and optimization.
Clew-ICU receives patient data from various sources, including Electronic Health Record (EHR) data and medical device data, which is then analyzed in near real-time to present calculated insights and notifications.
“We are proud to have received this landmark FDA clearance and deliver a first-of-its-kind product for the industry, giving healthcare providers the critical data that they need to prevent life-threatening situations,” said Gal Salomon, Clew CEO.
“AI can be a powerful force for change in healthcare, enabling assessment of time-critical patient information and predictive warning of deterioration that could enable better informed clinical decisions and improved outcomes in the ICU,” said Dr. David Bates, Medical Director of Clinical and Quality Analysis in Information Systems at Mass General Brigham healthcare system in Boston and Clew Advisory Board member.