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Cebreo Medical Reports CE Mark Approval of NeuroBuds for Ambulatory EEG Monitoring

Shots: Cebreo Medical has reported the CE Mark approval of its NeuroBuds device to be used unassisted by the patient at home for extended, ambulatory electroencephalogram (EEG) monitoring NeuroBuds, designed to resemble a hearing aid, minimizes the stigma & burden of long-term EEG monitoring, enabling comfortable, unassisted use for ~3mos. with repeat measurements Cebreo Medical…
September 15, 2026

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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…
September 4, 2026

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United Imaging Healthcare Receives CE Mark for Dual Wide-Coverage CT Systems

Shots: United Imaging Healthcare has received CE Mark certification for uCT SiriuX and uCT SiriuX Ultrix, described as the world’s first dual wide-coverage CT family, enabling commercial availability across the EU Built on a Twin-Ring Gantry architecture, the systems combine dual-wide 16cm Ultrix detectors with 2 liquid-metal-bearing X-ray tubes to support synchronized whole-organ dynamic imaging,…
September 4, 2026

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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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