Forbes July 8, 2025
Healthcare robotics pioneer Mendaera announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its handheld robotic system, Focalist, which aims to enhance ultrasound guided needle placement across a variety of medical and healthcare specialties. Specifically, the system integrates the use of a handheld module, real-time ultrasound imaging and proprietary software to simplify needle positioning, depth-tracking and placement to enable simplicity, consistency and reproducibility in needle based procedures.
Why is this important?
Image-guided needle placement is one of the most fundamental procedures across numerous specialties, including for accessing vital organs (e.g., for biopsies), establishing vascular access (e.g., central or arterial lines) and for managing pain and anesthesia (e.g., sedation for procedures). Furthermore, these procedures often...
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