Eyemate System for Remote Glaucoma Management Obtains FDA Breakthrough Device Designation
Implandata Ophthalmic Products announced today that its Eyemate system for digitally enabled remote patient monitoring and management of glaucoma has obtained Breakthrough Device Designation (BDD) from the US FDA. A BDD is only assigned for breakthrough technologies that have the potential to provide more effective treatment of life-threatening or irreversibly debilitating diseases in order to provide patients and physicians more timely access to such technologies without compromising safety.
The patented Eyemate system is the world’s only clinically-validated product used for comprehensive remote glaucoma monitoring. It empowers patients with the ability to measure their intraocular pressures from anywhere and any time, and then automatically send that information in real time to their doctor. This information empowers doctors to adjust glaucoma therapy based on a patient’s current condition rather than make therapeutic adjustments only during an office visit.
“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 as 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 Eyemate system, helping to improve their health outcomes,” said Max G. Ostermeier, CEO and Founder of Implandata.
Robert N. Weinreb, MD, Chair and Distinguished Professor of Ophthalmology at the University of California, said, “The BDD for the Eyemate system is exciting news. 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.”
“Our clinical experience with the Eyemate system in Europe has been very positive, as evidenced by over 100,000 pressure readings that have been taken by patients who have had the Eyemate sensor implanted. The real-life information provided by the Eyemate system enables eye care specialists to better understand a patients’ disease and to apply more effective treatments in a timely fashion. And patients are empowered via self-monitoring, resulting in improved therapy adherence,” said Kaweh Mansouri, MD, MPH, Consultant Ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland, Adjoint Professor at the Department of Ophthalmology, University of Colorado, Denver, and Implandata’s Chief Medical Officer.