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Globus Medical Receives the CE Mark for Excelsius3D

Shots: Globus Medical has reported the CE Mark approval for Excelsius3D intelligent 3-in-1 imaging system, expanding the company’s Excelsius Ecosystem & enhancing the capabilities of its ExcelsiusGPS robotic navigation system Excelsius3D combines 3D cone-beam CT, 2D fluoroscopy & digital radiography in one mobile intraoperative platform, integrating with ExcelsiusGPS for seamless imaging & robotic navigation to…
2 days ago

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HighLife Receives CE Mark Approval for Clarity Valve for Use with the HighLife TMVR System

Shots: HighLife received CE Mark approval for its HighLife Clarity Mitral Heart Valve for use with HighLife TMVR System for adults with symptomatic mod. to sev. or sev. mitral valve regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair Four-year follow-up of the first 35 consecutively treated pts showed durable valve performance, with…
August 28, 2026

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Masimo Secures CE Mark for smartSedLine to Advance Anesthetic Management

Shots: Masimo has received CE Mark approval for smartSedLine, a brain function monitor featuring an AI-powered Patient State Index (PSi) algorithm designed to provide greater responsiveness to brain activity & improved stability during anesthesia smartSedLine continuously displays four real-time bilateral frontal EEG waveforms & key parameters, incl. the 0–100 PSi reflecting sedation level, supporting more…
August 19, 2026

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Revvity Debuts SuperFlex Prenatal Screening System

Shots: Revvity has launched SuperFlex, a compact immunoassay platform for rapid, reliable prenatal screening in lower-volume laboratories & clinics, incl. preeclampsia testing SuperFlex offers an affordable, low-waste setup with annual maintenance, simplified operation and minimal training, plus flexible throughput with continuous loading and results in as little as 14min SuperFlex supports first & second-trimester biochemical…
August 11, 2026

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Galaxy Therapeutics Secures CE Mark for SEAL Embolization System

Shots: Galaxy has received CE Mark under the EU MDR 2017/745 for its SEAL Embolization System, following assessment by Notified Body DQS Medizinprodukte. Launch expected across selected EU markets, with FDA’s PMA application underway The SEAL Embolization System is an intrasaccular device for endovascular treatment of ruptured & unruptured wide-neck intracranial aneurysms, supporting aneurysm sizes…
August 4, 2026

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SpinaFX Medical Secures CE Mark MDR Approval for Triojection System

Shots: SpinaFX has received MDR CE Mark for its Triojection System, which delivers a controlled ozone-oxygen gas mixture for procedures. Triojection also received US FDA’ IDE approval in Jun 2026 SpinaFX is engaging distribution partners to launch Triojection in priority markets, initially targeting pts with persistent pain from contained herniated discs who have failed conservative…
July 16, 2026

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HistoSonics Reports CE Mark Approval of Edison System for Unresectable Liver Tumors

Shots: HistoSonics has reported CE Mark approval of its Edison System for the non-invasive mechanical destruction of liver tumors, incl. the partial or complete destruction of unresectable liver tumors using histotripsy Approval was supported by clinical evidence, incl. HOPE4LIVER trial, which demonstrated a 90% local tumor control rate at 12mos. across liver tumor types with…
July 14, 2026

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Roche
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Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Shots: Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…
July 9, 2026

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Median Technologies Receives CE Mark for eyonis LCS to Detect and Diagnose Lung Cancer

Shots: Median Technologies has received CE Mark for eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer In testing eyonis LCS has showed 93.3% sensitivity & 92.4% specificity, with 68% reduction of False Positives & 66% reduction of False Negatives, minimizing unnecessary follow-ups eyonis Lung Cancer Screening is an AI-powered computer-aided detection & diagnosis…
July 3, 2026

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