December 6, 2023 – OtoNexus Medical Applied sciences, the developer of the Novoscope ultrasound otoscope for instant and computerized differentiation of bacterial center ear infections, is happy to announce its latest participation within the U.S. Meals and Drug Administration Safter Applied sciences Program (STeP).

STeP is a groundbreaking initiative launched by the FDA to determine and expedite the event and analysis of progressive medical units that present a big benefit over all at present accessible choices in that units chosen for this system will present radical enhancements in affected person care and supply affected person security. STeP goals to supply sufferers with extra well timed entry to those medical units by offering STeP winners with accelerated improvement and evaluate, and interactive and well timed communications, together with dash discussions, enhanced regulatory assist, real-time suggestions and direct recommendation, and different assist. To qualify, the product should present a big profit over at present accessible choices.

In 2022, simply 14 units have been chosen for the elite Safer Applied sciences Program, an progressive initiative of the FDA's Heart for Gadgets and Radiological Well being (CDRH) designed to determine and speed up the event of units anticipated to enhance security, remedy, and prognosis.

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