Eyeyon Medical Ltd. has won CE mark approval for its flagship product, Endoart, a synthetic implant that replaces the human endothelium, which the body can’t regenerate. Designed to treat chronic corneal edema, it could help to reduce the long wait times for human donor corneas. Approval was based on a first-in-human trials involving 22 patients who received Endoart implants and were followed for 24 months.
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.
LONDON – Wise Srl has received CE marking for its cortical strip electrode, validating the underlying flexible electronics technology and opening the door to the development of implantable devices for long-term neurostimulation.
Information Data Systems Inc., doing business as One Drop, has earned the CE mark for its blood glucose prediction analysis engine to accurately forecast glucose levels up to eight hours in advance. The artificial intelligence (AI)-powered tool is indicated for people living with prediabetes, type 2 diabetes, including those on oral medications and/or insulin regimens, and gestational diabetes.
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
PARIS – One month before the Medical Device Regulation (MDR) comes into force in the EU, the European Association of Notified Bodies (Team-NB) has released the results of its latest annual survey. This survey of CE-marked medical devices compiled data from 26 notified bodies who were members of Team-NB at the end of 2020. According to Team-NB’s 2020 survey, a total of 18,784 valid CE certificates had been issued by last year, representing an increase of 35% over 2010.
Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.
Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.
Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which is designed to be used with the company’s Percept PC DBS device. Percept received U.S. FDA clearance in June 2020 and CE mark in January 2020.
LONDON – Following circulating tumor cells and cell-free tumor DNA, a new type of liquid biopsy is poised for commercial rollout after Datar Cancer Genetics Ltd. secured CE marking for Trublood, a method for isolating tumor cell clusters. In fact, the clusters do not consist solely of tumor cells, but can also include endothelial cells, erythrocytes, stromal cells, leukocytes, platelets, and cancer-associated fibroblasts. They are held together by cell-to cell-adhesion proteins.