(JW Insights) Jun 16 -- Siemens Healthineers’ heart surgery robot CorPath GRX gained marketing approval in China, Yicai Global reported on June 15.

China’s National Medical Product Administration announced this month that it gave the okay for Siemens Healthineers' CorPath GRX to be marketed in the country. The regulator also noted that it will tighten the product's post-marketing supervision to safeguard patients.
Siemens Healthineers said last month that it had halted the use of CorPath GRX in cardiac surgery as it did not meet expectations. The firm's Chinese branch explained that the move was a strategic adjustment based on feedback from sales regions around the world, not because of any concerns about the product's safety, effectiveness, and supervision.
CorPath GRX is the first surgical robot to enter the innovation green channel, a fast-track approval process introduced by the NMPA in 2016 to speed the entry of innovative medical devices into the market, The Paper reported, citing Siemens Healthineers China.
“We have cooperated with the NMPA and accepted strict technical audits, inspection, and testing to fully verify the safety and effectiveness of the product despite a long review time,” the firm added.
CorPath GRX was the world's first robotic-assisted platform for endovascular surgery, developed by Corindus Vascular Robotics, a US medical robots business acquired by Siemens Healthineers for $1.1 billion in 2019. Since then, it has been known as the vascular robotics division of Siemens Healthineers, said the Yicai Global report.