ASX Health Stocks: Nova Eye faces FDA hurdle in the US, Uscom recognised in China
Health & Biotech
Health & Biotech
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Nova Eye (ASX:EYE) has received feedback from the US FDA in relation to its 510(k) submission for clearance of the company’s new iTrackTM Advance canaloplasty device in the US.
Following the feedback, the company says it does not expect to receive marketing clearance prior to December 31, as previously stated.
“The regulatory pathway for marketing clearance for canaloplasty in the USA is extremely rigorous and complex,” acknowledged Nova Eye CEO, Tom Spurling.
Nova Eye’s current product, the original iTrack canaloplasty microcatheter, remains the only device in the USA with an indication for canaloplasty.
“We continue to have an excellent opportunity in the USA with the original iTrack canaloplasty microcatheter, because of growing surgeon interest in canaloplasty and a favourable reimbursement environment,” added Spurling.
The EYE share price fell 2% on the news.
Uscom’s (ASX:UCM) subsidiary Uscom China was selected as one of the first Innovative Small and Medium-sized Enterprises (SMEs) by Beijing Chaoyang Development and Reform Committee (DRC).
The result was formally published on the website of Chaoyang District People’s Government of Beijing Municipality on November 25.
Uscom says its selection marks another recognition of Uscom China’s ‘innovation ability, professionalism and growth’.
Uscom manufactures calibration devices for optimising respiratory device performance.
Its products include the USCOM 1A, the Uscom BP+, and the Uscom SpiroSonic digital ultrasonic spirometry technologies and the VENTITEST and VENTITEST-S.
To date, 90 China-funded projects have supported USCOM 1A clinical research and more than 200 Chinese papers on USCOM 1A clinical applications have been published.
“Endorsements such as these demonstrate the regard in which Uscom, and specifically Uscom China, is held internationally and support its potential in the market,” said Uscom’s exec chairman Professor Rob Phillips.”