MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Cybersecurity is pleased to announce its key role in obtaining U.S. Food and Drug Administration (FDA) marketing authorization for the Quell wearable neuromodulation device as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. Quell is the first FDA-authorized device treatment for fibromyalgia.
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MCRA was retained by NeuroMetrix to support strategy and development of a breakthrough designation request that was granted by the FDA for use of Quell to treat fibromyalgia. MCRA then led the development and preparation of the De Novo Request and collaborated with NeuroMetrix to resolve all FDA questions during the review of the De Novo. Both accomplishments – FDA granting the breakthrough designation in July, 2021 and granting the De Novo request in May, 2022 – were achieved within one year. This highlights the intensive communication and collaboration between the NeuroMetrix, FDA, and MCRA teams to expedite fibromyalgia patients’ access to Quell to reduce the symptoms of their debilitating condition.
Shai N. Gozani, M.D., Ph.D., Chief Executive Officer of NeuroMetrix said, “It has been a pleasure working with the MCRA Neuro regulatory team. Their expertise was fundamental in the success of both our breakthrough and de novo submissions in such a short period of time. We are looking forward to working with other divisions of MCRA such as the International Regulatory Affairs as we strive to expand the market for NeuroMetrix products.”
John Doucet, MCRA’s Vice President of Regulatory Affairs – Neuromodulation and Evolving Therapies, said, “We are delighted to have collaborated with NeuroMetrix to achieve these important milestones for patients on behalf of the company. I want to specifically thank the FDA Office of Neurological and Physical Medicine Devices for the collaborative and interactive nature of their review. Their commitment to the spirit of the breakthrough device program played a significant role in expediting patient access to the first FDA-authorized device treatment for fibromyalgia.”
David Lown, President of MCRA, commented, “At MCRA, we recognize the importance of speed and focus in delivering for our clients. Every day a patient suffers from fibromyalgia is one day too many. This first ever device to treat fibromyalgia getting FDA authorization in less than one year demonstrates our commitment to our clients in delivering more, better, first!”