Implandata Ophthalmic Products has obtained the CE mark for today that its EYEMATE-SC biosensor. This device is used in conjunction with the EYEMATE system for digitally enabled remote glaucoma monitoring and management. The EYEMATE-SC is an improved version of its predecessor product.
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The patented EYEMATE system is the world’s only clinically-validated product used for comprehensive remote glaucoma monitoring. US FDA Breakthrough Device Designation was obtained in April 2021. This device allows patients to self-measure their intraocular pressure, and then automatically sends gathered information to their eye doctor or to cloud-based storage. This information enables eye doctors to obtain close information about therapy effectiveness and to adjust treatment based on a patient’s current condition rather than make therapeutic adjustments based on a single measurement of IOP acquired during an office visit.
Max G. Ostermeier, CEO and founder of Implandata said: “Obtaining CE mark for our less invasive EYEMATE-SC sensor as part of our validated EYEMATE system is another important step forward for the company to transform glaucoma care. This new version is expanding the addressable glaucoma patient segment and is more readily and safely implanted than the earlier device. With CE mark, we will start to launch the product with various eye centres across Europe.”
Kaweh Mansouri, consultant ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland, and one of the lead investigators in the clinical study validating the EYEMATE-SC biosensor added: “With CE mark of the EYEMATE-SC biosensor we can now start to introduce the EYEMATE system into our clinical routine, which we have eagerly waited for. Our team has been very pleased with the safety and the performance of the product in our clinical study and is very happy by how well the product is accepted by our patients. EYEMATE will help us to make more informed therapeutic decisions faster. This technology empowers patients, resulting in improved adherence with therapy and less worries about undetected IOP peaks and glaucoma progression.”
