Mendaera receives FDA Clearance for handheld robotic system for ultrasound-guided procedures

Mendaera receives FDA Clearance for handheld robotic system for ultrasound-guided procedures

System integrates handheld robotics, real-time ultrasound, and advanced software to help clinicians consistently and accurately place needles during procedures like organ access, biopsies, vascular access, and therapy delivery.

FDA clears Mendaera's robotic system for ultrasound-guided needle placement

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Mendaera’s Focalist, a handheld robotic system.The post FDA clears Mendaera’s robotic system for ultrasound-guided needle placement appeared first on Medical Device Network.

Mendaera gets FDA 510(k) clearance for handheld robotic system

Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims to combine handheld robotics with real-time imaging to enable clinicians to place needles with precision. Mendaera said the system integrates robotics, ultrasound imaging and advanced software to make medical procedures more accessible.  Among Focalist’s features are touchscreen targeting, robotic needle positionin…

Mendaera receives FDA clearance for handheld robotic system for ultrasound-guided needle placement

Mendaera, a healthcare technology company focused on developing robotics that can be deployed universally in medicine, has received US 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 […]