Staci Kearney

Staci Kearney, PhD, is the founder and CEO of Elevation Strategic Consulting, specializing in regulatory guidance for digital pathology. In this conversation, she unveils the FDA's new rules for Laboratory Developed Tests (LDTs) as they shift to medical device oversight. Staci addresses compliance challenges that labs face, emphasizing the importance of clear labeling and record-keeping. She elaborates on critical deadlines approaching in May 2026 and the need for strategic planning amid a rapidly evolving regulatory framework.