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Nova Eye gains EU MDR certification to bolster European glaucoma device growth

Story Highlights
  • Nova Eye Medical won EU MDR certification for its iTrack glaucoma devices, enabling CE marking and ongoing European sales.
  • The certification secures a growing European revenue stream and strengthens Nova Eye’s global regulatory and competitive position in ophthalmic devices.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Nova Eye gains EU MDR certification to bolster European glaucoma device growth

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Nova Eye Medical ( (AU:EYE) ) has issued an announcement.

Nova Eye Medical has secured European Union Medical Device Regulation certification for its iTrack product portfolio, enabling CE marking and confirming the robustness of its quality and regulatory systems. The company, which generated US$3.1 million in European sales in 2025, sees Europe accounting for 15% of its US$21 million global revenue base and growing at double-digit rates.

The new certification supports continued commercial supply of iTrack devices across Europe under the stricter MDR regime and strengthens Nova Eye’s global regulatory standing for future product registrations and expansion initiatives. This milestone is expected to underpin the company’s growth strategy in ophthalmic devices by safeguarding a key market and enhancing its competitive positioning in glaucoma treatment technologies.

The most recent analyst rating on (AU:EYE) stock is a Hold with a A$0.15 price target. To see the full list of analyst forecasts on Nova Eye Medical stock, see the AU:EYE Stock Forecast page.

More about Nova Eye Medical

Nova Eye Medical is a medical technology company focused on developing, manufacturing and selling proprietary ophthalmic treatment technologies and devices for glaucoma. Its portfolio includes the iTrack Advance minimally invasive glaucoma surgery device for mild to moderate disease and the Molteno3 drainage device for severe glaucoma, with global sales and manufacturing hubs in the U.S. and New Zealand.

YTD Price Performance: 13.64%

Average Trading Volume: 489,746

Technical Sentiment Signal: Hold

Current Market Cap: A$42.72M

Learn more about EYE stock on TipRanks’ Stock Analysis page.

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