Press release: BIOS granted FDA Breakthrough Device Designation
Biologic Input Output Systems Granted Breakthrough Device Designation by FDA
21 March, 2024 | Source: Biologic Input Output Systems, Inc.
Biologic Input Output Systems, Inc. (BIOS), a neurotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to investigate the use of the BIOS system to allow users to control and to receive sensory feedback from robotic prosthetic upper limbs. Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
The BIOS System is a peripheral nerve interface intended to be used for control of and sensory feedback from prostheses in individuals with limb loss.
To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment and review while maintaining regulatory standards for pre-market approval. With Breakthrough Device Designation, the BIOS system could become available as a new treatment option sooner for people with upper limb loss.
“All of us at BIOS are very excited with this news, and we believe we are one step closer to providing life-changing technology to those who need it the most.” Wendy Huang, COO, BIOS
About Biologic Input Output Systems, Inc
Biologic Input Output Systems, Inc, is a neurotech company, in the field of neural interface technology. BIOS is in the clinical stage and leverages neurotechnology, AI and advanced materials to allow the human brain to communicate with digital devices on a natural and intuitive level. Founded in 2021, the development of this technology platform was spun out of the University of Utah. For more information, visit https://www.biologicinputoutputsystems.com/.
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