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.
Price: 9.45, Change: -0.66, Percent Change: -6.51
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。