Implandata Ophthalmic Products, a digital health company, has received Breakthrough Device Designation (BDD) from the Food and Drug Administration (FDA) for its Eyemate system for digitally enabled remote patient monitoring and management of glaucoma.
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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 Eyemate system is the world’s only clinically-validated product used for comprehensive remote glaucoma monitoring. It gives patients the ability to measure their intraocular pressures from anywhere and anytime, 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.
Max G. Ostermeier, CEO and founder of Implandata said: “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 authorisation, the Eyemate system will now be entitled to Medicare Coverage of Innovative Technology for at least four years, offering beneficiaries predictable access to the breakthrough Eyemate system, helping to improve their health outcomes.”
Robert N. Weinreb, chair and professor of ophthalmology at University of California, and Implandata medical advisor added: “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 management of glaucoma patients.”
