JOGO Health, a value-based virtual care company that leverages proprietary digital interventions to provide comprehensive rehabilitation for chronic pain and neuromuscular conditions, has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its chronic lower back pain product, JOGO-CLBP. During the COVID-19 pandemic, the FDA granted 510(k) exemption for JOGO’s foundational platform, JOGO-Gx.
“Receiving Breakthrough Device Designation isn’t easy. It requires a solid clinical foundation and bold thinking. JOGO-CLBP addresses the root cause of chronic low back pain through a proprietary protocol. JOGO Health is fully committed to the journey of providing people with new therapeutic options for the treatment of chronic pain,” said Sanjai Murali, Founder and CEO of JOGO Health.
“Electromyography biofeedback has been studied since the 1970s to treat chronic pain and other neuromuscular conditions. But, due to technological limitations in delivering the treatment virtually and lack of awareness and training, the modality is not in practice. JOGO’s 21st Century technology and modern telemedicine-based approach will make EMG biofeedback widely available to patients. The Breakthrough Device Designation by the FDA will accelerate this.” added Gary Krasilovsky, PT, PhD and Chief Scientific Officer of JOGO Health.