"Curexo, a local medical device company, said that the Ministry of Food and Drug Safety has approved CUVIS-spine, a robot-assisted spine surgery device.
The device helps conduct spinal screw insertion, and its benefits include conducting accurate surgery within 1 millimeter of error range and can perform both open surgery and minimally invasive surgery as it is compatible with two-dimensional (C-Arm) and three-dimensional images (O-Arm).
Based on the approval, the company plans to expand the devices use to secure clinical data. Afterward, the company will use the data to enter the global robot-assisted spine surgery device market. Besides, the company is trying to establish an overseas sales agency as it expects to acquire the European Conformite Europeenne Mark (CE) certification in the first half of next year.
“With the commercialization of CUVIS-spine, our company will continue to develop further to enhance the device’s surgical planning functions,” Curexo CEO Lee Jae-jun said. “We will also apply for the U.S. Food and Drug Administration (FDA)’s approval next year.”
As several major spinal implant companies have already introduced robot-assisted spine surgery devices in the U.S., the company believes that it can no longer delay its FDA application, Lee added.
According to WinterGreen Research, a market research firm, the global spinal surgery robot market is expected to grow from $26 million in 2016 to $2.77 billion in 2022."
The device helps conduct spinal screw insertion, and its benefits include conducting accurate surgery within 1 millimeter of error range and can perform both open surgery and minimally invasive surgery as it is compatible with two-dimensional (C-Arm) and three-dimensional images (O-Arm).
Based on the approval, the company plans to expand the devices use to secure clinical data. Afterward, the company will use the data to enter the global robot-assisted spine surgery device market. Besides, the company is trying to establish an overseas sales agency as it expects to acquire the European Conformite Europeenne Mark (CE) certification in the first half of next year.
“With the commercialization of CUVIS-spine, our company will continue to develop further to enhance the device’s surgical planning functions,” Curexo CEO Lee Jae-jun said. “We will also apply for the U.S. Food and Drug Administration (FDA)’s approval next year.”
As several major spinal implant companies have already introduced robot-assisted spine surgery devices in the U.S., the company believes that it can no longer delay its FDA application, Lee added.
According to WinterGreen Research, a market research firm, the global spinal surgery robot market is expected to grow from $26 million in 2016 to $2.77 billion in 2022."
Source: Korea Biomed
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