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Clinical validation of the enhanced HYLA blood sensor with its new oxygenation indicator is currently underway.
February 28, 2025
By: Michael Barbella
Managing Editor
Inspira Technologies OXY B.H.N. Ltd. has integrated a next-generation oxygenation indicator into its artificial intelligence (AI)-powered HYLA blood sensor technology, designed to rapidly detect critical oxygen-related conditions without the need for intermittent blood draws.
The company is confident the integration of this advanced indicator is a significant enhancement in critical care monitoring. The technology is designed to provide data through real-time and continuous oxygenation therapy monitoring, enabling clinicians to rapidly detect tissue hypoxia and the early warning signs of respiratory complications. The advanced AI-powered system is designed to indicate the level of lung function and to monitor vital blood parameters, positioning HYLA as a potential game-changer in the $2.5 billion point-of-care testing and arterial blood gas analyzer market.
Clinical validation of the enhanced HYLA blood sensor—with its new oxygenation indicator—is currently underway and preliminary clinical results will be shared in the near future. The non-invasive technology uses sophisticated optical sensors and machine-learning algorithms to deliver continuous monitoring of blood parameters and oxygen levels; Inspira Technologies expects to submit the product to the U.S. Food and Drug Administration (FDA) for regulatory clearance in the second half of 2025.
“This advancement marks an important step in transforming critical care monitoring,” Inspira Technologies CEO Dagi Ben-Noon said. “The integration of this new oxygenation indicator into HYLA will enable healthcare providers to monitor and respond to changes in tissue oxygenation in real time. We continue to advance in our clinical evaluation program and look forward to sharing preliminary clinical results with the public in the near future, which we hope will further validate the HYLA’s technological offering and superiority over traditional blood sensors in the market.”
The addition of advanced oxygenation monitoring capabilities further strengthens HYLA’s position as a comprehensive blood monitoring solution, according to Inspira Technologies. When combined with the FDA-cleared INSPIRA ART100 system, this technology aims to provide a more complete approach to patient care by enabling continuous, non-invasive monitoring while maintaining consciousness during treatment.
Inspira Technologies is a medical technology company in the life support and respiratory treatment arena. It has developed Augmented Respiration Technology (INSPIRA ART), a device poised to revolutionize the $19 billion mechanical ventilation market. With 20 million intensive care unit patients suffering from acute respiratory failure each year, many of whom rely on mechanical ventilators, the INSPIRA ART offers a potential alternative by elevating and stabilizing decreasing oxygen saturation levels in minutes without a ventilator, with patients being awake during treatment. The INSPIRA ART is being equipped with a clip-on HYLA blood sensor, a real-time continuous blood monitoring technology, aiming to alert physicians of changes in a patient’s condition without the need for intermittent actual blood samples.
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