Implandata Ophthalmic Products Announces CE Mark for EYEMATE-SC Biosensor

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

How To Control a Radio Frequency (RF) Process

The radio frequency welding and manufacturing process uses electromagnetic energy and pressure to fuse and permanently bond vinyl, thermoplastic, and coated materials to produce a specific product - all according to customer requirements. Using this RF sealing process, a distinct, one-piece perpetual bond is formulated that is both solid and resistant to ripping or tearing. But how is this process controlled, and with what specific tools? Read on.

Cartessa Aesthetics’ Innovative Multi-Modality Treatment Leads Demand for Non-Invasive Body Procedures

PHYSIQ is a novel, dual-modality system that offers deep heat to target tissue and electrical muscle stimulation (EMS) to re-educate muscle – all from one device and in one session.

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.

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 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 Ophthalmic Products 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”

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.