FDA clears handheld robotic system for ultrasound-guided needle procedures

Editor's Note

Mendaera has received US Food and Drug Administration (FDA) clearance for its Focalist system, a compact robotic device that aims to improve precision in ultrasound-guided needle-based procedures. Fierce Biotech reported the news July 9.

As detailed in the article, Focalist device is intended to assist with a range of high-volume interventions—approximately 200 million per year—including central catheter placement, fine needle aspiration biopsies, and local drug or anesthetic delivery. It weighs about the same as a mobile phone and clips onto a handheld ultrasound probe. It reads real-time imaging feeds, tracks needle depth, and uses a touchscreen interface to signal correct alignment and readiness for insertion.

Mendaera plans a limited commercial launch in 2025, beginning with urology applications such as percutaneous kidney stone removal, the outlet reports. The company expects to expand into additional specialties nationwide in 2026. Other future plans include leveraging artificial intelligence to automatically identify anatomical features such as arteries and to develop telehealth capabilities that would allow specialists to remotely observe and guide frontline clinicians during needle-based procedures.