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Mendaera receives FDA 510(k) clearance for robotic system for ultrasound-guided needle placement - Interventional News

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Mendaera’s Focalist, a handheld robotic system designed to improve the precision of ultrasound-guided needle placement. According to the company in a recent press release, the system combines real-time imaging with a handheld robotic control to assist clinicians in performing a wide range of minimally invasive procedures and settings. Its features include robotic needle p…
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Interventional News broke the news in on Thursday, July 10, 2025.
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