Inspira Technologies has secured approval from Sheba Medical Center’s Ethics Committee in Israel to carry out a clinical study of its Hyla blood sensor.

The medical technology company is planning to commence the Hyla blood sensor’s clinical study in the first quarter of the year.

It plans to conduct the study in patients undergoing open-heart surgery at the Sheba Medical Center.

Developed using machine learning-based algorithms, the Hyla non-invasive optical blood sensor aims to provide continuous and real-time measurements of blood parameters during extracorporeal procedures.

These parameters are expected to potentially provide physicians with alerts of sudden changes in a patient’s condition or extracorporeal blood oxygenation circuit performance.

The Hyla blood sensor is being designed to act as a stand-alone device or an integrated part of the Augmented Respiration Technology (INSPIRA ART) system or Alice Device.

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Inspira Technologies’ INSPIRA ART system is designed to rebalance oxygen saturation levels while patients are awake and breathing spontaneously, therefore reducing the need for mechanical ventilation. The system makes use of the hemo-protective flow approach.

The Alice extracorporeal blood circulation device provides cardiac and pulmonary support.

Hyla is expected to help improve patient outcomes while lowering complications and associated costs.

The clinical study aims to assess how the blood parameters measured by the new sensor correlate against the results of a standard blood gas analyser.

It is a prospective data collection study designed to integrate clinical research into the product development cycle.

Inspira’s products have not yet received approval from any regulatory entity.