VISENSIA

The Visensia® system is a software accessory that enhances patient monitoring by employing advanced signal processing to integrate multiple vital signs (heart rate, respiratory rate, temperature, oxygen saturation, and blood pressure) into a single 'Visensia® Index.' This index, derived from a model based on historical clinical data, serves as a quantitative measure of a non-paediatric high dependency patient's deviation from physiological normality, providing clinicians with an alert when significant changes occur.

Visensia® is a software accessory designed for use with standard multi-parameter patient monitors or clinical information systems, operating on a personal computer. Its primary purpose is to assist healthcare professionals in monitoring non-paediatric high dependency care patients by consolidating multiple physiological signals into a single, easily interpretable metric. The system accepts inputs such as heart rate, respiratory rate, temperature, blood pressure, and oxygen saturation. Through advanced signal processing, Visensia® calculates the 'Visensia® Index,' which is a weighted average of these vital signs. This index represents the patient's current physiological condition relative to a baseline of normality, providing a continuous assessment of their status. The scientific basis of the Visensia® Index lies in its ability to fuse data from either four or five vital signs, with the model for determining 'normality' and deviations derived from historical clinical data. The Visensia® with Alert feature acts as an adjunctive decision support tool, alerting clinicians when the Visensia® Index surpasses a predefined threshold. This indicates a significant change in the patient's physiological status that warrants attention, but it does not replace traditional vital sign monitoring or alarms. Clinical testing data has demonstrated the effectiveness of the Visensia® system and its alert function, showing a correlation between the activation of alerts and actual patient deterioration. The system is designed for use on standard PC hardware with no direct patient contact, posing minimal electrical safety risk.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How is the 'weighted average' for the Visensia® Index calculated, and what is the specific contribution or weighting of each of the four or five vital signs?; What specific 'historical clinical data' was used to establish the model of 'normality' for the Visensia® Index, and how diverse was this dataset in terms of patient populations and conditions?; Can the default threshold for the Visensia® Alert be customized by clinicians based on specific patient populations or individual patient needs, and if so, what guidance is provided for such customization?; What were the specific endpoints and outcomes measured in the clinical testing that demonstrated the 'effectiveness of Visensia®' and the correlation between its alerting function and 'patient deterioration'?; How does the 'advanced signal processing' algorithm account for potential artifacts or noise in the input physiological signals from various multi-parameter monitors?