Allison Kumar
Allison Kumar serves as the Global Head of Regulatory and Clinical Affairs for Spectral AI. Allison has been working with Spectral AI since 2016 as an executive advisor to steer the company’s complex clinical and regulatory roadmaps. With over 25 years of experience in the medical device industry, she spent a decade at the FDA’s Center for Devices and Radiological Health (CDRH), where she served as a lead reviewer for peripheral vascular devices and Sr. program manager for CDRH’s emergency preparedness and medical countermeasures portfolios. Her expertise is uniquely aligned with Spectral AI’s mission to revolutionize wound care through AI-driven diagnostics, having led the review of novel combination products and advanced medical software systems at FDA and subsequently working with numerous companies to bring their innovations to market.
Her leadership at Spectral AI is informed by a robust background in high-performance team building and experience with inter-agency collaborations between FDA and the CDC, BARDA, and the Department of Defense. A recipient of the FDA Commissioner’s Special Citation and the Outstanding Service Award, she is a recognized thought leader who has authored publications on clinical trial design, traumatic injury and autonomous critical care. Ms. Kumar earned her B.S. in Biomedical Engineering from Virginia Tech, holds a Graduate Certificate in Biohazardous Threat Agents from Georgetown University, and is an alumna of the Harvard National Preparedness Leadership Institute.