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CUREXO Gains CE Mark Approval for CUVIS-spine Robot
Curexo received approval under the CE Mark for the CUVIS-spine surgical robot. The company is also planning to apply for FDA clearance.CUVIS-spine guides and supports the pedicle screw to the correct position using a robotic arm, one-step surgical tools and a real-time location sensor. Real-time patient position monitoring can correct the surgical plan in real time, and can help reduce radiation exposure for the patient and O.R. staff.CUVIS-spine provides imaging compatibility on not only C-arms, but also O-arms. The device received approval by Korea's Ministry of Food and Drug Safety and launched late last year in the region.The company is also developing CUVIS-joint for potential launch in 2020.According to the CEO of CUREXO, "Certifying the CE certificate for CUVIS-spine is another big step taken after last year's MFDS certificate. Also, achieving the CE certificate for the CUVIS-spine is meaningful because now CUREXO is aiming for the global market with a self-developed surgical robot. The following task will be FDA approval and entering the U.S. market, which is number one in surgical robots.By Julie A. Vetalicehttps://www.orthoworld.com/curexo-gains-ce-mark-approval-for-cuvis-spine-robot/
Date : 2020-08-12
Orthoworld
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CUREXO Launches Robot-Assisted Spine Surgery Device
Curexo launched the CUVIS-spine robot-assisted spine surgery device following approval by Korea's Ministry of Food and Drug Safety.CUVIS-spine guides and supports the pedicle screw to the correct position using a robotic arm, one-step surgical tool and real-time location sensor. Real-time patient position monitoring can correct the surgical plan in real time, and can help reduce radiation exposure for the patient and O.R. staff.Curexo seeks to establish an overseas sales agency, as it expects to receive CE Mark approval in 1H20 and will also apply for FDA clearance.The company is also developing CUVIS-joint for launch in 2020.By Julie A. VetaliceSource: https://www.orthoworld.com/curexo-launches-robot-assisted-spine-surgery-device/
Date : 2020-08-12
Orthoworld