Inspira Technologies has reported that its HYLA blood sensor line (blood sensor) attained 95% accuracy versus conventional blood gas analysers.
This is claimed to aid in offering sustained and real-time blood monitoring expertise as against standard blood gas analyser systems that are utilised in hospitals which need recurrent blood draws.
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The company now plans to make a submission under a 510(k) pathway with the US Food & Drug Administration (FDA) in the second half of next year.
Created for integration with the INSPIRA ART100 device of the company, the new sensor technology could provide continuous and real-time data collection and analysis of blood samples.
The company sought FDA clearance for INSPIRA ART100 in September this year with approval expected in the first half of next year.
Inspira expects the deployment of the HYLA blood sensor will streamline ICU operations and boost patient care by offering key insights and alerts.
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By GlobalDataFurthermore, the new blood sensor could potentially enhance medical procedures and the efficiency of other devices.
The new device is claimed to be highly precise, not invasive, durable and a versatile tool for various procedures. It also features a modular design that complements currently available medical devices.
In developing the HYLA, the company leveraged domestic lab assessments and hospital partnerships to carry out clinical research and development.
These efforts have helped in outlining the disposable materials and approaches for the sensor, aligning with HYLA’s planned razor blade business model.
Even though the sensor is chiefly created for INSPIRA ART devices, the company is planning to provide a standalone variant of the blood sensor.
Inspira Technologies CEO Dagi Ben-Noon said: “With our sensor technology, we are not only enriching our INSPIRA ART device line but also forging a path into the disposables market, setting the stage for groundbreaking developments in healthcare.”
The novel solutions of the company are said to facilitate in offering direct blood oxygenation and possibly cutting down the requirement for standard mechanical ventilation approach.
