Moon Surgical announced today that its Maestro system for surgical robotics received CE mark approval in Europe. To date, the French-American surgical robot maker said 50 patients in Europe underwent Maestro-assisted surgery. These took place in a clinical trial led by Dr. Guy-Bernard Cadière in Brussels, Belgium. The company designed Maestro to support surgeons in […]
CE Mark
Innovation Zed wins CE mark for insulin pen add-on device
Innovation Zed announced that it received CE mark approval in Europe for its InsulCheck Dose add-on device. Dublin, Ireland-based Innovation Zed designed the InsulCheck Dose device as a single-unit add-on device for pen injectors. It automatically captures dose value dialed, injection event time stamps and temperature. The device also captures mounting and unmounting events. Get […]
Medtronic wins CE mark for extravascular defibrillator system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Aurora EV-ICD and Epsila EV MRI SureScan system. The Aurora EV-ICD and Epsila EV defibrillation lead treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The EV-ICD (extravascular implantable cardioverter-defibrillator) system offers the live-saving benefits of traditional ICDs. However, it […]
Varian wins U.S., European clearance for radiotherapy systems
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 […]
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) […]
