Nexalin Technology, Inc. announced the appointment of Michael Nketiah as Senior Vice President of Quality, Clinical and Regulatory. Mr. Nketiah is an expert in regulatory affairs, as well as clinical and quality assurance, specializing in US FDA and international regulatory approvals, with over 23 years of experience working directly with the FDA in the medical device and life sciences industries, for both prescription and OTC products. His experience includes multiple regulatory submissions of 510(k)s, PMAs, De Novo, IDEs, Q-Submissions, FDA meetings and international regulatory approvals for a wide variety of innovative and novel medical device and in vitro diagnostic device companies.

His experience includes developing quality systems, authoring various US FDA regulatory submissions, and assisting with clinical operations. Mr. Nketiah also has extensive experience in gaining US and international approvals for clinical investigations and/or product launch in Europe, North America, Australia/New Zealand, and Asia. Prior to joining Nexalin, Mr. Nketiah served in senior roles at various companies which include VP of Quality & Regulatory Affairs at Intervenn Bioscience, Tivic Health, Previvo Genetics, Sr. Director of Quality and Regulatory Affairs at PROCEPT BioRobotics, Director of Quality at Crux Biomedical, Inc. and at Biomimedica, Inc. Michael holds two Bachelor of Science degrees in Chemistry and Mechanical Engineering, and an MBA degree.