Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance and CE mark for its Halcyon and Ethos systems. Both radiotherapy systems feature Varian’s HyperSight imaging solution. HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. The images help in the daily localization of patient tumors and their uses […]
CE Mark
NeuroLogica wins CE mark for mobile CT systems
NeuroLogica announced today that its Elite mobile computed tomography (CT) systems received CE mark approval in Europe. The Samsung Electronics subsidiary received approval for its OmniTom Elite, BodyTom Elite and CereTom Elite mobile CT systems. “The achievement of this certification sheds light on our continued dedication to bringing innovative solutions to hospitals and clinics globally,” […]
Getinge partners with Medtronic to make Radiant balloon-expandable covered stent
Getinge today announced a partnership with Medtronic (NYSE:MDT) over the Radiant balloon-expandable stent, which received CE mark. Radiant is designed for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system. It maintains perfusion to renal arteries when used in combination with the stent graft. The medtech giant said that Radiant is […]
Insulet wins CE Mark for Omnipod 5 for children 2 and up
Insulet (Nasdaq:PODD) announced today that it received CE mark approval in Europe for its Omnipod 5 automated insulin delivery system. Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts–based Insulet said it represents the first CE-marked tubeless hybrid closed loop system The latest-generation Omnipod 5 […]
Senseonics wins CE mark approval for 180-day Eversense E3 CGM
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), […]
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 […]