China’s National Medical Product Administration has granted a certificate to the Monarch surgical platform of Johnson & Johnson MedTech, setting the ground for the innovation to tap the immense Chinese market, Chinese media reported recently.
The regulatory greenlight signals that Monarch, a robot-assisted surgical (RAS) platform for peripheral lung biopsy, is now eligible for adoption in China for clinical operation.
This development also made Monarch the first minimally invasive RAS platform for medical procedures on lungs and bronchus to be officially licensed in China.
The certification is also a milestone for Johnson & Johnson’s medical unit outside the United States. Previously, Monarch only secured the FDA approval in its home market.
Johnson & Johnson acquired Auris Health, a medtech firm that’s behind the invention of Monarch, for US$3.4 billion in 2019, paving the way for its entry into the booming surgical robot market.
Monarch came out with a purpose to uncover visual treatment pathways for procedures on adult patients’ lungs, bronchus and windpipe, so as to aid diagnostics and treatment.