Nexalin Technology Welcomes Carolyn Shelton to Executive Team
Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) is excited to announce the addition of Carolyn Shelton as the Senior Vice President of Clinical, Quality, and Regulatory Affairs. With over three decades of experience in the medical device industry, Shelton brings invaluable expertise in regulatory compliance, quality assurance, and clinical development to the company.
Expertise in Medical Devices
Shelton's career showcases a remarkable track record of leadership roles within prominent companies. She previously worked at Openwater Health, LLC as the Vice President of Regulatory, Quality, and Clinical, where she laid the groundwork for a medical device start-up. Shelton was pivotal in securing FDA Breakthrough designation and spearheading early feasibility clinical trials.
Regulatory Leadership
Prior to her time at Openwater Health, she gained significant experience at Advanced Sterilization Products, Inc. (ASP), where she held the position of Vice President of Worldwide Regulatory, Quality, Medical Affairs, and Product Stewardship. In this capacity, she played a critical role in ASP's integration following its separation from Johnson & Johnson, crafting strategic regulatory plans and successfully navigating various regulatory submissions and audits.
Clinical Excellence
At Medtronic, Shelton directed regulatory strategies and managed submissions for a varied portfolio of medical devices. Her leadership was integral in achieving global approvals and enhancing quality across the organization. Earlier in her career, she held key positions at Smith & Nephew, contributing to developing global regulatory strategies and ensuring compliance for a diverse array of medical products.
Commitment to Innovation
Mark White, CEO of Nexalin Technology, expressed enthusiasm for Shelton's arrival, stating, "We are delighted to welcome Carolyn to our executive team at such an exciting time for Nexalin. Her extensive experience in navigating complex regulatory landscapes and fostering high-performing teams will be instrumental as we pursue global regulatory clearances and FDA Breakthrough Device designations for our Deep Intracranial Frequency Stimulation (DIFS) technology."
Addressing Mental Health Needs
Shelton shared her excitement regarding her new role, highlighting the pressing need for effective, drug-free alternatives for treating mental health diseases. "Mental health issues such as anxiety, depression, and insomnia significantly affect individuals and their families. Nexalin's innovative DIFS neurostimulation technology has the potential to offer a much-needed treatment option without the side effects associated with traditional medications," she said.
Future Prospects and Contributions
With Nexalin on the cusp of major regulatory initiatives both domestically and internationally, Shelton looks forward to leveraging her expertise to guide the company through these crucial processes. She aims to collaborate with the Nexalin team to bring groundbreaking therapies to market and improve the lives of countless patients and their families.
About Nexalin Technology, Inc.
Nexalin Technology is dedicated to designing and developing advanced neurostimulation products aimed at addressing the global mental health crisis. The company's range of non-invasive products is designed to provide relief to individuals struggling with various mental health conditions. Utilizing bioelectronic medical technology, Nexalin aims to penetrate deep brain structures associated with these disorders, offering enhanced patient responses without adverse effects. The Nexalin Gen-2 15 milliamp neurostimulation device has received approvals in several countries.
Frequently Asked Questions
What role has Carolyn Shelton taken at Nexalin Technology?
Carolyn Shelton has been appointed as the Senior Vice President of Clinical, Quality & Regulatory Affairs at Nexalin Technology.
What experience does Carolyn Shelton bring to Nexalin?
Shelton brings over 30 years of experience in the medical device industry, including leadership roles in regulatory compliance and clinical development.
What is Nexalin's primary focus in mental health?
Nexalin focuses on developing innovative neurostimulation products to provide drug-free alternatives for mental health treatment.
What technology is Nexalin developing?
Nexalin is developing Deep Intracranial Frequency Stimulation (DIFS) technology, aimed at addressing mental health issues effectively.
What are Nexalin's future plans regarding regulatory approvals?
Nexalin plans to pursue global regulatory clearances and FDA Breakthrough Device designations for its DIFS technology.
