December 6, 2023- OtoNexus Medical Technologies, the developer of the Novoscope ultrasound otoscope for immediate and automatic differentiation of bacterial middle ear infections, is excited to announce its recent selection into U. S. Food and Drug Administration Safter Technologies Program (STeP).
STeP is a pioneering initiative introduced by the FDA to identify and expedite the development and review of innovative medical devices that offer a significant advantage over all currently available options, in that devices selected for the program provide radical improvements in patient care and patient safety. STeP aims to provide patients with more timely access to these medical devices by providing STeP awardees expedited development and review, and interactive and timely communications, including sprint discussions, enhanced regulatory support, real-time feedback and direct advice, and other support. To qualify, the product must offer a significant advantage over currently available options.
In 2022, just 14 devices were selected for the elite Safer Technologies Program, an innovative initiative of the Center for Devices and Radiological Health (CDRH) division of the FDA designed to identify and expedite the development of devices expected to significantly improve safety, treatment, and diagnostics.