Digital Glaucoma Monitoring Device Given Breakthrough Status

EYEMATE system is the world’s only clinically validated product used for comprehensive remote glaucoma monitoring. It is an important step towards developing a digital platform for using intraocular pressure and other diagnostic data to enhance the management of glaucoma patients.

This digital innovation has recently obtained BDD (Breakthrough Device Designation) status from the U.S. The measurement system consists of an implantable microsensor, responsible for pressure sensing, and an external handheld device responsible for transferring energy to the microsensor telemetrically.

Max G. Ostermeier, CEO and Founder of Implandata states: “We are extremely pleased to move forward under the FDA BDD program, as we will benefit from additional FDA input during the premarket development as well during the submission process and through an expedited review once the submission is filed. With FDA market authorization, the EYEMATE system will now be entitled to Medicare Coverage of Innovative Technology for at least 4 years, offering beneficiaries predictable access to the breakthrough EYEMATE system, helping to improve their health outcomes.”

Implandata, the company behind EYEMATE, aims to lead the digital transformation of glaucoma care and improve data access between patients and Doctors globally.