Glaukos Corporation Secures EU MDR Certification for iStent infinite® and Leading MIGS Therapies, Marking First Approvals Under New EU Regulatory Framework

Reuters
26 Jun
Glaukos Corporation Secures EU MDR Certification for iStent infinite® and Leading MIGS Therapies, Marking First Approvals Under New EU Regulatory Framework

ALISO VIEJO, Calif.--(BUSINESS WIRE)-- Glaukos Corporation $(GKOS)$, a leading ophthalmic pharmaceutical and medical technology company, has announced receiving European Union Medical Device Regulation $(MDR.AU)$ certification for its iStent infinite® and other micro-invasive glaucoma surgery (MIGS) technologies, including iStent inject® W. This marks the company's first regulatory clearances under the new EU regulatory framework. These certifications highlight that the devices meet the stringent quality, safety, and effectiveness standards set by the EU MDR. The approval supports Glaukos' efforts to expand its presence in Europe and propel its global Interventional Glaucoma initiatives. Glaukos, the global market leader in MIGS, plans to commence commercial launch activities for these therapies in the coming months.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Glaukos Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20250625924718) on June 25, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10