21 Mar China grants regulatory approval for the geko® device
Sky Medical Technology has welcomed the news that its geko device, an innovative neuromuscular electrostimulator, has received regulatory approval for use in China. This marks a significant milestone for the company and represents a major growth opportunity in one of the world’s largest and most dynamic healthcare markets.
With a regulatory system well known for its rigorous standards, Firstkind’s regulatory team collaborated closely with local partners in China to meet the necessary requirements for the device registration. A dedicated variant of the geko device – the geko device (C3) – was then developed specifically to cater to the Chinese market.
With a population exceeding 1.4 billion and a rapidly ageing demographic, China is experiencing a surging demand for healthcare services, pharmaceuticals, and medical devices. This is reflected in the China wearable medical devices market size, which was estimated at $1.08billion in 2023 and is projected to grow at a CAGR of 28.5% from 2024 to 2030.
Making a significant impact
“This latest regulatory approval follows hard-on-the-heels of geko device registration in Japan and so we are highly delighted to now also announce, in such quick succession, registration of the geko device in China also, said Sky CEO and Founder, Bernard Ross. “This achievement represents not just the hard work and dedication of our regulatory team, but also the potential for Sky to make a significant impact on healthcare in both these major markets.”
Read the full announcement here
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