SmartCardia SA has been granted the CE Medical Device Certification for its cordless wearable medical multi-sensor monitoring system, SmartWearable. The device measures a complete set of physiological and vital parameters at clinical accuracy and can provide early warning of a health risk.
A major challenge with today’s wearables is to measure and provide clinically meaningful information to doctors and patients that could help diagnose a disease or prevent a deterioration of health condition. SmartCardia’s wearable device enables emergency-room doctors to continuous monitor and analyse patient’s important vital signs – including the Electrocardiogram (ECG), heart rate, heart rate variability, pulse rate, oxygen saturation (SpO2), blood pressure variations and trends, skin temperature, activity and posture – to provide early warning of a health risk.
Unlike current monitoring systems which rely on bulky sensors and cables that limit patients’ movement, SmartCardia’s small patch, which is attached to the patient’s chest, contains a fusion of wireless sensors on a single unit, thereby eliminating the need for cables. To compliment their device, SmartCardia developed SmartNeuralNet, a machine learning technology that powers its medical wearables. The system has been validated in several clinical trials in leading hospitals globally. “There is a tremendous response and demand for the system from the different clinics and patients we have been working with”, said Srinivasan Murali, CEO and co-founder of SmartCardia.
The startup has now been granted the CE Class IIa certification, which serves as a spring board for its market entry. This certification signifies a product’s compliance with the applicable EU regulations and enables the commercialization of products in all European countries. Large-scale production has already started and the device will be launched on the Swiss and EU markets in the coming days.
(Press release/ran)
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