Nexalin Technology Appoints Carolyn Shelton as SVP of Clinical, Quality & Regulatory Affairs
核心洞察
Carolyn Shelton, a seasoned medical device expert, joins Nexalin Technology (搜索) as Senior Vice President to lead clinical, quality, and regulatory affairs.
Shelton's role includes overseeing clinical studies and regulatory submissions, crucial for Nexalin's global expansion and FDA Breakthrough Device designations.
Her experience includes leadership roles at Openwater Health, Advanced Sterilization Products (ASP), Medtronic, and Smith & Nephew, ensuring regulatory compliance.
Nexalin Technology (搜索), Inc. has appointed Carolyn Shelton as its new Senior Vice President of Clinical, Quality & Regulatory Affairs. Shelton brings over 30 years of experience in the medical device industry to the role, where she will oversee clinical studies, quality systems, and regulatory submissions.
Shelton's career includes leadership positions at Openwater Health, where she built the regulatory and clinical framework for a medical device start-up, securing FDA Breakthrough designation and leading early clinical trials. She also held a VP role at Advanced Sterilization Products (ASP), a division of Fortive, where she managed global integration post-divestiture from Johnson & Johnson and ensured EU MDR compliance. At Medtronic, she directed regulatory strategy and submissions for a diverse portfolio of medical devices.
"We are delighted to welcome Carolyn to our executive team at such an exciting time for Nexalin," said Mark White, CEO of Nexalin Technology (搜索). "Her deep experience in successfully navigating complex global regulatory landscapes and leading high-performing teams is truly impressive."
Shelton expressed her enthusiasm for joining Nexalin, stating, "I’m excited to join Nexalin at this pivotal time, especially given the huge unmet need for effective, drug-free alternatives to treat mental illness. Mental health conditions such as anxiety (搜索), depression (搜索), and insomnia (搜索) not only affect the lives of patients but also have a profound impact on their families. Nexalin’s innovative DIFS (搜索) neurostimulation technology offers a much-needed solution for individuals seeking treatment without the side effects of medication."
Nexalin Technology (搜索) focuses on developing non-invasive neurostimulation products to combat the global mental health epidemic. Their Deep Intracranial Frequency Stimulation (DIFS (搜索)) technology is designed to penetrate deep into the mid-brain to treat mental health disorders. The Nexalin Gen-2 15 milliamp neurostimulation device has already been approved in China, Brazil, and Oman.