Israel-based MedTech start-up Olive Diagnostics has received the CE mark approval for Olive KG, its hands-free, non-invasive, AI-based optical device for urinalysis.

Designed to be mounted on any toilet, Olive KG enables high-quality analysis of crucial parameters in the patients’ urine, without user intervention.

The device measures parameters including red blood cells, proteins, Nitrites, pH levels, alongside volume, pressure, colour, and frequency of urination, among others.

It leverages optics to detect the molecular components in the urine, and generates real-time personal data, secured as per the GDPR and HIPPA guidelines, and accessed through the cloud.

Olive Diagnostics is currently preparing to file an application with the US Food and Drug Administration (FDA), seeking regulatory approval for Olive KG in the US.

Olive Diagnostics CEO Guy Goldman said: “The milestone of receiving the CE Marking provides validation for our vision and technology and paves the way for us to enter the European market.

“Olive KG is already installed at several assisted living facilities in Holland, and we believe that our device will transform medical care to one of non-invasive prevention, aiding patients and healthcare providers to detect diseases earlier, even before symptoms appear.”

The continuous monitoring feature of the device alerts users about conditions including urinary tract infection (UTI) and kidney stones, before the onset of symptoms.

When pre-symptomatic issues related to UTIs are identified, patients can be administered prophylactics to reduce the chances of hospitalisation.

Olive KG can detect kidney stones in men, a few weeks before the onset of painful symptoms, facilitating their treatment before hospitalisation.

Based on its application, the device forms a critically important tool for the elderly, where early detection can improve the quality of life and level of care, said Olive Diagnostics.

According to the company, the urinalysis device that can be used to early diagnose the development of diseases can reduce operating costs and the need for hospitalisations.

Olive Diagnostics is currently commercialising the device in Europe, through assisted living facilities, outpatient facilities, and telemedicine providers.