New World Medical has received European Union Medical Device Regulation (MDR) certification for three of its established glaucoma surgical devices: the Ahmed Glaucoma Valve (AGV), Ahmed ClearPath (ACP), and KDB GLIDE.
Announced on October 6, 2026, the certification confirms that all three products meet the EU's updated regulatory requirements, allowing the company to continue supplying the devices to surgeons across Europe.
The products were previously available in European markets under the Medical Device Directive (MDD), which has been progressively replaced by the more stringent MDR framework. The transition introduces additional requirements relating to clinical evidence, product safety, traceability, and post-market surveillance.
For New World Medical, the certification represents an important step in maintaining its established European presence while providing a regulatory foundation for further expansion of its glaucoma portfolio.
"We are proud to reach this important milestone for New World Medical," said Raymond Kong, Chief Commercial Officer. "MDR certification reflects the tremendous effort and collaboration across our organization and enables us to continue supporting glaucoma surgeons in Europe with innovative solutions for their patients."
The three certified devices represent different approaches to the surgical management of glaucoma.
The Ahmed Glaucoma Valve is an established glaucoma drainage device designed to help regulate intraocular pressure by directing aqueous humor away from the anterior chamber. Ahmed ClearPath provides another drainage implant option for surgeons managing patients who require surgical intervention.
KDB GLIDE, meanwhile, is a surgical instrument used to perform excisional goniotomy, offering a different approach to improving aqueous outflow through the trabecular meshwork.
Together, the devices form part of New World Medical's broader portfolio of surgical technologies aimed at reducing intraocular pressure and addressing different patient needs.
With MDR certification secured for these three products, New World Medical is now prioritizing European certification for the Ahmed ClearPath ST (ACP ST), a small-tube glaucoma drainage device designed to offer surgeons additional procedural flexibility.
The ACP ST is already approved in more than 20 countries worldwide and is intended for use in the management of refractory glaucoma. However, it has not yet received EU MDR certification.
"European surgeons have expressed growing interest in the ACP ST, a next-generation small-tube glaucoma drainage device designed to provide additional surgical flexibility," Kong said.
According to the company, discussions are ongoing with its notified body as it works toward securing the necessary European certification.
The development reflects New World Medical's wider efforts to extend access to its glaucoma technologies across international markets. Founded by Dr. A. Mateen Ahmed, the US-based company develops surgical devices for glaucoma management, with a portfolio that also includes the STREAMLINE Surgical System and VIA360 Surgical System.
While the latest certifications concern devices already marketed in Europe, the company's next regulatory objective could broaden the surgical options available to European glaucoma specialists.
