Serenno Medical, a portfolio company of Alon Medtech Ventures, has introduced a new automatic device, dubbed Sentinel, for continuous monitoring of kidney function.
For use within the hospital, the Sentinel device works by continuously measuring urine output and volume to help identify cases of Acute Kidney Injury (AKI).
Sentinel device is compatible with existing catheters, as well as urine bags and needs a short and simple, non-invasive installation.
Serenno said the device intends to automatically and accurately detect small changes in kidney function, providing actionable data to the nursing staff.
The system can be used in any patient condition or hospital environment and also in the complicated intensive care unit and operating room environments.
In a clinical trial undertaken at several centres in Israel, the Sentinel system demonstrated the ability to accurately detect low and high urine flow rates in a range of patients, environments, and conditions, and patient positions. It was effective while being used with mobile hospital beds and even during surgeries.
Results demonstrated over 96% accuracy and reliability in more than 40 patients and 1,300 hours of monitoring.
Serenno Medical co-founder and CEO Tomer Lark said: “The successful results of our first clinical trial will allow the company to move forward to manufacturing the device for commercial usage and enable us to bring this best-in-class product to the global medical markets.
“We expect to receive FDA clearance for the system during 2020 and believe that our patent-pending device has the potential to become the standard-of-care in the OR and ICU, benefiting millions of patients around the world.”
AKI affects about 19 million patients worldwide every year and occurs in 60% of all ICU patients and 10% of all hospital admissions.