Mendaera Handheld Robotic System Receives FDA Clearance

July 8, 2025 — Mendaera, Inc., a healthcare technology company focused on developing robotics that can be deployed universally in medicine, recently announced  it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its handheld robotic system, Focalist. The novel system is designed to simplify and enhance the precision of ultrasound-guided needle placement — a technically demanding procedure performed across many specialties and care settings. The company is commencing a limited launch with select medical institutions.