Washington, May 8, 2023 /PRNewswire/ – MCRA, LLC, is a leading medical device-focused regulatory consulting firm and clinical research organization (CRO) integrating US and international regulatory affairs, clinical trial operations, payment and market access, healthcare fulfillment, cybersecurity, quality assurance and Japan. Distribution Logistics (DMAH) is pleased to announce its role in helping Noctric Health obtain marketing authorization for its NTX100 Tonic Motor Activation (NTX100 TOMAC) system in De Novo’s request from the US Food and Drug Administration (FDA). The device is indicated to reduce symptoms of primary moderate-to-severe restless legs syndrome (RLS) and improve sleep quality in drug-resistant adults.
The NTX100 TOMAC System is an externally worn medical device that applies low-level electrical stimulation to nerve fibers in the legs to treat restless legs syndrome (RLS). RLS is the second most common sleep disorder in the world and has contributed to what the Centers for Disease Control and Prevention has labeled a public health epidemic. Affecting more than 10% of Western adults, and 81% of those with clinical RLS seeking help from their physician, RLS places a heavy economic burden on the health care system. Noctrix Health has been named a breakthrough tool. May 2020 To use NTX100 TOMAC to treat drug-resistant RLS.
MCRA’s team of neurology, digital health and biochemistry experts has been retained by Noctrix Health to provide strategy, development and de novo submissions to the FDA and to address all FDA inquiries during the de novo review. A de novo motion is filed. September 2022 and given in April 2023. This short review period demonstrates the deep connection and collaboration between the Noctrix Health, FDA and MCRA teams to accelerate the NTX100 TOMAC system for the indicated patients and reduce RLS symptoms, improve sleep quality and improve quality of life. .
John DockettMCRA’s Vice President of Regulatory Affairs – Neuromodulation and Evolutionary Therapies said, “We are proud to partner with Noctrix Health to achieve this important milestone for the company. The timeline for developing, submitting and reviewing the de novo application has been shortened. With MCRA’s broad and deep regulatory expertise in neurology, digital health, cybersecurity, biochemistry, and other areas. In particular, I would like to thank the FDA’s Office of Neurological and Physical Therapy Devices for the collaborative and interactive nature of their review.
Shree Raghunathan“It is a real pleasure to work with MCRA’s team of experts,” said the CEO of Noctrix Health. .
MCRA is pleased to continue to support neuroscience innovation in the medical device industry by helping clients navigate global regulatory challenges.
About MCRA, LLC: MCRA is a privately held independent medical device, diagnostic and biologics clinical research organization (CRO) and consulting firm. MCRA provides its clients with industry expertise by integrating its six business value drivers: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance and distribution logistics to drive dynamic, market-leading efforts from new concepts to commercialization. MCRA’s integration of these key value-creating initiatives provides unparalleled value to its clients. MCRA has offices Washington DC, Hartford, CT, New York, New YorkAnd Tokyo, Japan. and serves nearly 1,000 customers worldwide. Major areas of medical expertise include orthopedics, spine, biology, cardiovascular medicine, diagnostic imaging, wound care, artificial intelligence, dentistry, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology. and in vitro diagnostic (IVD) devices and medical device cybersecurity. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), MCRA was founded in 2004. VB is in the headquarters. New York City and specialized in venture capital, private equity and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to funding healthcare innovation. www.vbllc.com
About Noctrix Health: Noctrix Health is a medical device company committed to developing high-quality, clinically proven medical technologies that improve the quality of life for patients with chronic health conditions. NTX100 Tonic Motor Activation (TOMAC) therapy is a first-in-class, non-pharmacological treatment for reducing symptoms of primary moderate-to-severe restless legs syndrome (RLS) and improving sleep quality in adults refractory to medication. For more information, visit www.noctrixhealth.com.
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Source MCRA, LLC