Inspira Technologies Reports 97.3% Accuracy HYLA Blood Sensor, Seeks FDA Clearance

Inspira Technologies announced that its HYLA blood sensor achieved 97.35% accuracy in the latest testing phase, marking a significant advancement from earlier clinical study data and supporting its upcoming FDA submission. The HYLA sensor provides continuous, non-invasive monitoring through optical measurement, eliminating the need for intermittent blood draws and delivering second-by-second data critical in operating rooms and critical care. The device is compatible with various medical procedures, including cardiopulmonary bypass, ECMO, continuous renal replacement therapy, and dialysis. While primarily designed to integrate with Inspira's ART device line, HYLA is being developed as a standalone product, aiming to penetrate the broader disposables market using a razor-and-blade recurring revenue model. CEO Dagi Ben-Noon emphasized that HYLA addresses urgent needs by enabling real-time alerts for rapid medical decisions, potentially improving patient outcomes. Despite this technological breakthrough, Inspira's stock faces challenges such as financial instability and bearish sentiment from analysts.