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Saved

Topic: CE Mark

article icon article
AI CE Mark Neuro

Study shows novel AI technology is better predictor of stroke than traditional methods

Boston-based medical technology company Elucid Bio, maker of the Food and Drug Administration (FDA)-cleared and […]

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Cardiology CE Mark Vascular

Kardium lands CE Mark for mapping and ablation device

Kardium announced that it received CE Mark approval in Europe for its Globe mapping and ablation […]

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CE Mark Digital Health Neuro

Akili wins CE mark for digital ADHD treatment

Akili Interactive announced today that it received CE Mark approval for its EndeavorRx video game for […]

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Cardiology CE Mark Structural Heart

Medtronic Moves the Needle in TAVI with New Indication

Medtronic has received CE mark for an expanded indication of its Evolut Transcatheter Aortic Valve […]

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Cardiology CE Mark Structural Heart

Medtronic Evolut TAVR system gets expanded label in Europe

Dive Brief: Medtronic’s Evolut transcatheter aortic valve implantation system now has an expanded CE mark […]

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Cardiology CE Mark Structural Heart

Medtronic wins CE mark for TAVI system in low-risk patients

Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve […]

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CE Mark Implantables Orthopedic

Smith & Nephew Regeneten bioinductive implant wins CE mark

Smith & Nephew (NYSE:SNN) announced today that its Regeneten bioinductive implant for rotator cuff procedures received […]

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CE Mark Imaging Oncology

Sirius Medical wins CE mark for non-radioactive localization system

Sirius Medical announced that it received CE Mark approval for its Sirius Pintuition non-radioactive tumor localization […]

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CE Mark Drug-delivery MedTech

ADA 2020 kicks off with key data on Medtronic's 780G, Insulet's Horizon

Dive Brief: The American Diabetes Association’s 80th Scientific Sessions begins Friday with two much-anticipated data […]

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CE Mark Drug-delivery MedTech

Medtronic lands CE Mark for MiniMed 780G insulin pump

Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its MiniMed 790G […]

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CE Mark Patient Monitoring Sensors

Dexcom lands CE Mark for G6 glucose monitor

Dexcom (NSDQ:DXCM) announced today that it received CE Mark approval in Europe for its G6 continuous […]

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CE Mark Drug-delivery Vascular

Surmodics wins CE Mark for drug-coated balloon

Surmodics (NSDQ:SRDX) announced today that it received CE Mark approval in Europe for its SurVeil drug-coated […]

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Cardiology CE Mark Structural Heart

SMT’s TAVR wins CE Mark for aortic stenosis

Sahajanand Medical Technology (SMT) announced today that its Hydra TAVR device has received the CE Mark […]

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CE Mark MedTech Ophthalmology

SightGlass Vision nets European approval for eyeglasses to reduce childhood myopia progression

SightGlass Vision received a CE mark allowing its first suite of lenses—for eyeglasses specially designed […]

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CE Mark MedTech Neuro

phenox announces European launch of its new thrombectomy devices

phenox has announced the full European launch of the pRESET 5–40 and pRESET LUX 4–20 […]

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CE Mark FDA Vascular

Merit Medical lands CE mark for Wrapsody endovascular stent graft

Merit Medical (NSDQ:MMSI) announced that it received CE Mark approval in Europe for its Wrapsody endovascular […]

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Cardiology CE Mark Diagnostics

Bardy Expands Home Enrollment Program for Cardiac Patch Monitor

Bardy Diagnostics is expanding the home enrollment program for its cardiac patch monitor and won […]

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Cardiology CE Mark Structural Heart

Edwards secures CE mark for Pascal tricuspid valve repair device

Dive Brief: Edwards Lifesciences on Monday announced it won a CE mark for its Pascal […]

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Cardiology CE Mark Structural Heart

Edwards Makes Gains in Tricuspid Regurgitation Repair with CE Mark

The Irvine, CA-based company said the Pascal repair system demonstrated high procedural success and significant […]

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CE Mark Neuro Pain Management

Nevro Senza Omnia SCS wins CE Mark

Nevro (NYSE:NVRO) announced today that it has received CE mark approval for the Senza Omnia spinal […]

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CE Mark Diagnostics Healthcare

Ortho Clinical Diagnostics Brings in CE Mark for Antibody Test

Ortho Clinical Diagnostics has received CE mark for its COVID-19 total antibody test. The CE […]

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CE Mark MedTech Patient Monitoring

OptiScan Biomedical Receives CE Mark for OptiScanner® 7000 for Automated Multivariate Monitoring of Metabolic and Hemodynamic Status of Patients in the Intensive Care Unit

Company Secures EU Certification for First-of-its-Kind Continuous Monitoring System Capable of Assessing and Trending Glucose, […]

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Cardiology CE Mark Patient Monitoring

LifeSignals Receives CE Mark for ECG Remote Monitoring Patch

LifeSignals, based in Fremont, California, announced that it received the CE Mark for its LifeSignals […]

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CE Mark Healthcare MedTech

Notified bodies saw CE marks spike in 2019 ahead of now-delayed MDR

Dive Brief: Notified bodies reported a 49% year-on-year increase in the issuance of new CE […]

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Cardiology CE Mark Surgery

Terumo Aortic gains FDA breakthrough designation for aortic arch repair device

Terumo Aortic this week said it received FDA breakthrough device designation for its Thoraflex Hybrid […]

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CE Mark Neuro Vascular

Cerus Endovascular’s 021 Contour neurovascular system approved in Europe

Cerus Endovascular has received CE Mark approval for its 0.021-inch Contour neurovascular system, compatible with […]

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CE Mark Neuro Vascular

Cerus Endovascular receives CE mark for its Neqstent Coil Assisted Flow Diverter

Cerus Endovascular has announced that it has received CE mark approval for its Neqstent Coil […]

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CE Mark Orthopedic Spine

Signus receives CE mark for ALIF and cervical cages

Signus has gained CE mark approval for the BIG ST (left) and JASPIS ST implants […]

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CE Mark Structural Heart Vascular

Abbott’s TriClip tricuspid valve repair system lands CE Mark

Abbott (NYSE:ABT) announced today that its TriClip transcatheter tricuspid valve repair system won CE Mark approval […]

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CE Mark MedTech

TISSIUM Receives CE Mark and Announces Manufacturing Compliance Certification from TÜV SÜD

Received CE Mark for its first sterile biodegradable sealant in a pre-filled syringe format Issuance […]

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CE Mark Orthopedic Spine

SpineGuard receives CE mark for DSG Connect platform

SpineGuard has announced that it has received the CE mark for the commercial release of […]

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Cardiology CE Mark Respiratory

CardioQuip’s Cooler-Heaters EU Cleared to Help With Respiratory Distress

CardioQuip, a firm based in College Station, Texas, won European regulatory approval (CE Mark) for […]

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CE Mark Respiratory

RAPIDPoint 500e Blood Gas Analyzer FDA Cleared to Help Ventilated Patients

To help address the COVID-19 emergency that’s taking over emergency rooms and intensive care units […]

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CE Mark Diagnostics

Thermo Fisher Granted CE Mark for COVID-19 Test

Thermo Fisher Scientific is bringing its diagnostic detects nucleic acid from SARS-CoV-2, the virus that […]

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CE Mark Diagnostics Radiology

EchoNous Receives EU Approval for Kosmos AI Ultrasound Platform

EchoNous announced that it has received the European CE Mark of approval for its Kosmos […]

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CE Mark MedTech

French startup Dianosic nets CE Mark for nosebleed-stopping balloon

A French startup has received a CE mark for a small, inflatable device designed to […]

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CE Mark Implantables Orthopedic

DePuy Synthes wins CE Mark for hip replacement dual mobility system

Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes announced that it won CE Mark approval for its Bi-Mentum dual mobility […]

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Cardiology CE Mark Neuro

TriGUARD 3 Wins CE Mark for Cerebral Protection During Transcatheter Heart Procedures

Keystone Heart Ltd. announced that is has received the European CE Mark for its TriGUARD 3, […]

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CE Mark Neuro Structural Heart

Rival to Boston Scientific device used in TAVR wins CE mark

Dive Brief: Keystone Heart, a unit of China’s Venus Medtech, said Tuesday it received a […]

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Original post by NeuroNews

Written by: Editors

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