FDA approval for the Israeli company that detects deterioration of Krona patients in intensive care

CLEW Medical, an Israeli startup company founded by serial entrepreneur Gal Solomon and his partner Avigdor Fiennes, reports today (Wednesday) that the groundbreaking artificial intelligence platform it has developed for monitoring patients and early detection of deterioration in their medical condition has received FDA approval for its early detection of instability. Blood in adult intensive care patients. This is the first FDA approval for this type of system, which was subsequently issued for the Emergency Approval (EUA) granted in June 2020 to CLEWICU’s model for detecting respiratory deterioration for the purpose of prioritizing treatment of corona and other intensive care patients.

The solution that won emergency approval in light of the corona plague

The unprecedented patient load created by the corona plague has flooded the need for quick and accurate decision-making in intensive care units. An effective risk assessment for the quality diagnosis of patients and adjustment of treatment plans requires the use of advanced tools that provide a detailed and comprehensive forecast, which will help the medical staff identify which patients are more prone to deterioration, and which are less so.

Through continuous monitoring, the CLEWICU system classifies patients according to risk levels and provides the medical staff with physiological information indicating the possibility of instability of the patient’s blood pressure. The system produces alerts for clinical deterioration up to eight hours in advance, allowing for early assessment and intervention in the provision of preventive treatment. The system also identifies low-risk patients, whose condition is not expected to deteriorate, thus enabling efficient and optimal use of the resources of intensive care units.

The system is already installed in Ichilov and Sheba

With the outbreak of the corona crisis in Israel, the system was installed in the corona wards of Sheba and Ichilov hospitals, in order to help them cope with the expected load as a result of the outbreak of the virus. CLEW’s technology will be integrated into the new control tower of Ichilov Hospital, which is used to control and monitor all the hospital’s wards and hospital beds.

How does technology work?

The analytical software uses artificial intelligence algorithms and machine learning models to detect the occurrence of clinical events in intensive care patients. The CLEWICU system receives data on patients from a variety of sources, including digital medical records (EHR) and medical devices. The data are analyzed almost in real time, presenting calculated insights and alerts to dedicated models of artificial intelligence, in order to provide an overall picture of the department.

“We are proud to receive this significant approval from the FDA and the opportunity to offer a first-of-its-kind product to the industry, which provides the medical staff with the critical information they need to prevent life-threatening conditions,” he said. Said Gal Solomon, CEO of Clow Medical.

“Artificial intelligence can bring about significant change in medicine, through rapid assessment of patient data and early warning of possible deterioration, supporting informed clinical decision-making and improving outcomes in intensive care units,” he said. Said Dr. David Bates, Medical Director of Clinical and Qualitative Surgery in Mass General Brigham Health Systems, and a member of the Clow Medical Advisory Committee.

“Clio Medical’s AI-based solution is a huge step forward in the field of intensive care, providing preventive and even life-saving information that allows for early intervention, reduces alarm fatigue among staff and may contribute to significant improvement in clinical outcomes,” he said. Said Professor Craig Lilly of the University of Massachusetts School of Medicine.

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