Koh Young gets OK from FDA for brain surgery robot

Koh Young Technology Inc., a South Korean developer of 3D optical inspection devices used in electronics manufacturing, said on Monday it got 501K approval from the US Food and Drug Administration (FDA) for a brain surgery robot Geniant Cranial (the global brand name of Kymero). 

Geniant Cranial is a stereotactic robotic guidance system that uses medical imaging to support complex procedures, including surgeries for epilepsy and Parkinson’s disease, brain tumor biopsies, and intracerebral hemorrhage operations.

Koh Young Technology is the number one company dedicated to developing 3D solder paste inspection (SPI) equipment. 

The company developed its first surgical robot, Kymero, in 2011 as part of a Korean government-funded project assigned by the Ministry of Trade, Industry, and Energy. In 2016, the company also received approval from the Ministry of Food and Drug Safety to produce and sell Kymero in South Korea.

After conducting clinical tests in South Korea, Koh Young Technology signed a contract with Yonsei University’s Severance Hospital in June 2020 to supply Kymero for surgical uses.

According to the Korea Institute of Science and Technology Information, the global robot market is expected to more than double to $12.7 billion with North America accounting for 62% by 2025 from $5.9 billion in 2020. 

Write to Jong-Hwan Won at won0403@hankyung.com