Innovate (VATE) said Tuesday that China's National Medical Products Administration has approved the MediBeacon Transdermal Glomerular Filtration Rate, or TGFR, monitor and sensor to assess kidney function in patients with normal or impaired renal function.
Lumitrace, or relmapirazin, injection is still under review in China and is expected to be approved by late 2025, the company added.
The TGFR technology uses Lumitrace along with the TGFR monitor and sensor to measure kidney function by tracking how the fluorescent agent is cleared from the body. In 2021, the Chinese regulator granted the TGFR an innovative medical device designation, the company said.
The technology, including Lumitrace, was also approved by the US Food and Drug Administration on Jan. 17, the company said, adding that MediBeacon is continuing to develop new TGFR products, including a next-generation sensor with improved software and algorithms.
Shares of Innovate fell about 6% in recent trading activity.
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