Senseonics (NYSE:SENS) announced today that it received CE mark for the next-generation Eversense E3 CGM system. Germantown, Maryland-based Senseonics offered its previous-generation continuous glucose monitor (CGM) with a 90-day wear time. Its next-generation Eversense E3 can be used for up to six months (180 days). Europe already had a 180-day Senseonics CGM system available (Eversense XL), […]
CE Mark
Ibex wins CE mark for AI-powered gastric cancer detection tech
Ibex Medical Analytics announced today that it received CE mark approval for its Galen gastric cancer detection solution. Tel Aviv, Israel-based Ibex uses artificial intelligence (AI) and machine learning technology to power its Galen platform for cancer diagnostics based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology. Galen won […]
DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes
DoMore Diagnostics announced that it received CE mark approval in Europe for its Histotype Px Colorectal deep learning algorithm. Oslo, Norway-based DoMore designed its Histotype Px Colorectal deep learning algorithm to predict colorectal cancer patient outcomes based on analysis of digital histology images. The company said in a news release that the algorithm, which builds […]
Optellum wins CE mark for AI-powered early lung cancer diagnostic tech
Optellum announced that it received CE mark for its artificial intelligence (AI)-powered Virtual Nodule Clinic software platform. Oxford, England-based Optellum designed the Virtual Nodule Clinic as a clinical decision-support tool for helping clinicians identify and track at-risk patients who present suspicious lung nodules that may or may not be cancerous. The platform received FDA 510(k) […]
Dexcom wins CE mark for next-gen G7 CGM, will begin European launch within weeks
Dexcom (Nasdaq:DXCM) announced today that it received CE mark approval in Europe for its G7 continuous glucose monitoring (CGM) system. The San Diego–based company has also submitted for an FDA 510(k) for G7 and awaits clearance in the U.S. Dexcom designed its next-generation CGM offering as an all-in-one wearable system. It warms up in 30 minutes […]
Roche launches its connected blood glucose meter in Europe
Roche announced today that it launched its Cobas Pulse system in select countries accepting CE mark approval in Europe. Basel, Switzerland-based Roche designed its Cobas Pulse system to combine the form factor of a high-performance blood glucose meter with simple usability and expanded digital capabilities comparable to that of a smartphone. The platform joins Roche’s connected […]
LumiraDx wins CE mark for C-reactive protein test
LumiraDx (NSDQ:LMDX) announced today that it received CE mark approval for its C-reactive protein PCR test. London-based LumiraDx designed its LumiraDx CRP test as a small and portable microfluidic immunoassay test used for the quantitative determination of C-reactive protein, delivering results within four minutes. According to a news release, the CRP measurement provides important information […]
Senseonics wins CE mark for remote glucose monitoring app for Android users
Senseonics (NYSE:SENS) announced today that its Eversense NOW remote monitoring app for Android received CE mark approval. Germantown, Maryland–based Senseonics already received such approval for the Eversense NOW iOS platform and can now offer it in Europe on the Android operating system. The company expects to make the Eversense NOW remote monitoring app for Android available […]
Baxter, Biomérieux win CE mark for test predicting persistent severe acute kidney injury
Baxter (NYSE:BAX) and Biomérieux (EPA:BIM) today announced CE mark approval for their Nephroclear CCL14 test. The companies designed the Nephroclear CCL14 test to predict persistent severe acute kidney injury (PS-AKI). It can be used to support timely clinical decision-making and care pathways, according to a news release. Baxter and Biomérieux plan to launch Nephroclear CCL […]
Cepheid wins CE Mark for COVID-19, flu, RSV combo diagnostic
Cepheid announced today that it received CE mark approval for its Xpert Xpress CoV-2/Flu/RSV Plus rapid molecular diagnostic. Sunnyvale, California-based Cepheid last month received FDA emergency use authorization (EUA) for the Xpert Xpress CoV-2/Flu/RSV Plus diagnostic. The company designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses […]
Medtronic’s Hugo robotic-assisted surgical system wins regulatory nod in Europe
Medtronic (NYSE:MDT) announced that it received CE mark approval in Europe for its Hugo robotic-assisted surgery system. Fridley, Minnesota-based Medtronic’s CE mark covers urologic and gynecologic procedures, which make up approximately half of all robotic procedures performed today, according to a news release. Last month, the company said it had been expecting to receive such […]
