OBS Medical Announces 510k Clearance for Visensia

OBS Medical Ltd, today announced that Visensia has received 510k clearance from the FDA. This is the fourth 510k clearance for Visensia since the original introduction of Visensia (Originally known as BioSignÔ) in 2005. Visensia was the first FDA cleared patient health index device with alerts on the market and is continuing to develop innovative leading edge products. VisensiaTM calculates a patient status index based on a weighted average using a non-linear fusion of five vital signs namely heart rate, oxygen saturation, blood pressure, skin temperature, and respiration rate (the “VisensiaTM model”). The patient status index is a single measure of the patient’s condition which provides early warning of patient deterioration.

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