The company’s team plans to demonstrate its proprietary SitePath™ site operations and TrialPathDx™ management system to expo attendees. Discussions will center on navigating complex regulatory landscapes, including 510(k), De Novo, and PMA programs, with an emphasis on aligning study design with submission requirements from the earliest stages of development.

Central to this year’s presentation is the appointment of Lisa Baumhardt as Senior Director of Regulatory Affairs. Bringing over three decades of experience from roles at GE Healthcare, IBM Watson Health, and Hyman, Phelps & McNamara, Baumhardt adds significant weight to the firm’s regulatory strategy. Her background includes advising on artificial intelligence in medical devices, a skill set that CovarsaDx CEO Chermaen Lindberg notes provides essential regulatory judgment for sponsors. Interested parties may book dedicated consultation slots via email or visit the booth for direct inquiries.