CLEW Medical, an Israeli MedTech startup, secured FDA clearance for its ‘CLEWICU’ predictive analytics platform. The company noted that this marks the first-of-its-kind AI-powered ICU solution for in-hospital remote care. This follows the Israeli firm’s Emergency Use Authorization (EUA) approval from the FDA back in June of 2020 - as a potential method of care to further help medical personnel comply with COVID-19 regulations and social distancing efforts.

"AI can be a powerful force"

"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.

CLEW’s platform combines data science and machine learning to accurately predict respiratory deterioration in ICU patients. The ML and AI algorithms go through continuous training to identify and even predict the likelihood of significant clinical events in ICU patients. The CLEWICU platform receives patient data from various sources, including Electronic Health Record (EHR) data and medical device data. The data is analyzed in near real-time to present calculated insights and notifications for dedicated AI models and provides a picture of overall unit status.

Essentially, the system helps optimize ICU priorities, and helps focus medical personnel on critical patients. The system provides notification of clinical deterioration up to eight hours in advance, enabling early evaluation and subsequent intervention for prompt, proactive patient care. It also identifies low-risk patients who are unlikely to deteriorate, therefore allowing ICU teams to invest less time and resources in stable patients.

"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 and CLEW Advisory Board member.