An implantable glaucoma biosensor has received CE mark approval for marketing in the European Union weeks after getting a nod from the FDA.
Implandata Ophthalmic Products, a digital health company with offices in Germany and San Diego, California has announced today that its EYEMATE-SC biosensor has obtained CE Mark.
This device is used in conjunction with the breakthrough EYEMATE system for digitally enabled remote glaucoma monitoring and management. The EYEMATE-SC is an improved version of its predecessor product.
This device empowers patients to self-measure their intraocular pressure, and then automatically sends gathered information in real-time 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 only a single measurement of IOP acquired during an office visit.
Max G. Ostermeier, CEO and Founder of Implandata states: “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 centers across Europe.”
Robert N. Weinreb, M.D., Chair and Distinguished Professor of Ophthalmology at University of California, San Diego and Implandata Medical Advisor comments: “Millions of individuals worldwide are at risk of permanent loss of their vision due to glaucoma. With the EYEMATE, intraocular pressure now can be monitored more closely to personalize treatment and avoid further vision loss.”
Kaweh Mansouri, M.D., M.P.H, Consultant ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland, Adjoint Professor at the Department of Ophthalmology, University of Colorado, Denver, and one of the lead investigators in the clinical study validating the EYEMATE-SC biosensor concludes: “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”