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Olive Diagnostics Nabs CE Mark for Optical Urinalysis Device

NEW YORK — Israeli startup Olive Diagnostics said Monday it secured CE marking for its optical toilet-mounted Olive KG instrument for passive urinalysis.

The firm said the instrument measures pH levels and concentrations of red blood cells, proteins, and nitrites and collects data on a patient's volume, pressure, color, and frequency of urination. The company claims the information collected by the device can be used to detect early signs of diseases and alert users up to weeks in advance of symptoms of urinary tract infections and kidney stones.

Olive Diagnostics said its device could help improve monitoring for elderly patients by transmitting data to physicians, family members, and caretakers. Its instrument is installed at several assisted living facilities in the Netherlands, and the company plans to sell the devices through other assisted-living facilities, outpatient facilities, and telemedicine providers in Europe, it said.

Olive Diagnostics said it is in the pre-submission phase for regulatory review of Olive KG by the US Food and Drug Administration.