Mendaera has received FDA clearance for its handheld robotic system, Focalist. The novel system is designed to simplify and enhance the precision of ultrasound-guided needle placement. The company is commencing a limited launch with select medical institutions with an initial focus in urology.
Focalist is designed to support precise and consistent needle placement across a breadth of users and clinical settings. The system integrates handheld robotics, real-time ultrasound imaging, and advanced software that makes medical procedures more approachable. Focalist features touchscreen targeting, robotic needle positioning, and continuous needle depth-tracking, to enable a reproducible procedure experience.
Mendaera will initiate a limited launch of its Focalist System in institutions during 2025, supporting procedures in urology such as percutaneous nephrolithotomy (PCNL), where precise access to the kidney is required, and expanding to other specialties thereafter. The company anticipates full commercialization of its Focalist System in 2026.
