Israeli medtech company earns FDA approval for use of ICU predictive model
CLEWICU is a artificial intelligence (AI) based ICU solution that can "predict hemodynamic instability in adult patients."
By ZACHARY KEYSERCLEW Predictive Analytics Platform in Support of COVID-19 Patients(photo credit: COURTESY OF CLEW)
Tel Aviv-based CLEW Medical, which specializes in AI-powered predictive analytics, has received US Food and Drug Administration (FDA) approval for the use of CLEWICU.CLEWICU is an artificial intelligence (AI) based ICU solution that can "predict hemodynamic instability in adult patients.""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 CLEW CEO Gal Salomon.This is the first FDA clearance for a device of this nature, and follows the FDA’s Emergency Use Authorization (EUA) for CLEWICU's respiratory deterioration model - approved in June."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, the Medical Director of Clinical and Quality Analysis in Information Systems at Mass General Brigham healthcare system and a CLEW Advisory Board member.With the ongoing coronavirus pandemic, CLEW's device allows physicians for quick and accurate decision-making in intensive care units. It can improve patient identification and treatment options by the use of "advanced tools that can provide comprehensive, predictive data to help medical professionals identify patients whose health conditions are likely to deteriorate, in addition to patients whose conditions are unlikely to deteriorate," CLEW said in a statement.CLEWICU works to continuously monitor and categorize ICU patients by risk level - using "AI-based algorithms and machine-learning models trained to identify the likelihood of occurrence of significant clinical events for patients in the intensive care unit" - and provides physicians with insights into a patient's likelihood of future hemodynamic instability. CLEWICU can also give fair warning 8-hours in advance, to notify physicians of a patient's deteriorating condition before it begins.The new AI model, which uses an algorithm that incorporates information compiled from nearly 100,000 ICU patients from the Electronic Health Record (EHR), is able to provide early detection of these illnesses "hours in advance." This gives room, as aforementioned, for early intervention and additional assessment, while reducing the risk of exposure to doctors and nurses treating the patients."CLEW's AI-based solution is a huge leap forward in ICU patient care, providing preemptive and potentially life-saving information that enables early intervention, reduces alarm fatigue and can potentially significantly improve clinical outcomes," stated Professor Craig Lilly, University of Massachusetts Medical School.
