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Topic: CE Mark

article icon article
Cardiology CE Mark Digital Health

Biobeat Receives EU Clearance for Vital Sign Monitoring with Wristwatch and Patch

Biobeat announced recently that it has received CE Mark approval for its patch and wristwatch […]

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CE Mark ENT

Dianosic lands CE Mark for intranasal bleeding device

Startup Dianosic (Strasbourg, France)  announced today that it has obtained the CE Mark for CAVI-T, a low-pressure […]

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CE Mark Implantables

LivaNova lands CE Mark for depression neurostimulation treatment

LivaNova (NSDQ:LIVN) said today that its vagus nerve stimulation therapy for treatment-resistant depression has won the […]

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Cardiology CE Mark Surgery

V-Wave Shunt for Relief of Heart Failure Symptoms Cleared in EU

Heart failure patients often suffer from high pressure within the left side of their hearts, […]

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CE Mark ENT

Tivic Wins EU Clearance for ClearUP Sinus Relief Device

San Francisco-based Tivic Health announced that the company has received CE Mark approval in Europe for ClearUP […]

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Cardiology CE Mark Implantables

V-Wave lands CE Mark for heart-failure device

V-Wave announced today that its Ventura interatrial shunt system has received the CE Mark. The Caesarea, […]

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CE Mark FDA Cleared Imaging

Mauna Kea lands 510(k), CE Mark for next-gen Cellvizio platform

Mauna Kea (ENT:MKEA) this week said it won FDA clearance and CE Mark approval for its […]

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Cardiology CE Mark Structural Heart

CryoLife wins CE Mark for ascending aortic prosthesis

CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for the On-X ascending aortic prosthesis (AAP) for […]

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CE Mark Surgery Vascular

Fist Assist Helps Prep Vein for Dialysis Surgery, Lead to Healthy Fistula

Fist Assist Devices, a small Silicon Valley firm, won the European CE Mark for its […]

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CE Mark Neuro Radiology

Contour Treats Brain Aneurysms Using Single Device

Cerus Endovascular, a firm based in Fremont, California, won the EU’s CE Mark for the […]

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Cardiology CE Mark

Abbott wins CE Mark for ICD device

Abbott (NYSE:ABT) this week announced it received CE Mark for its Gallant implantable cardioverter-defibrillator and cardiac […]

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Cardiology CE Mark Implantables

Abbott Picks Up Key Approval for ICD Technology

Abbott Laboratories has won CE mark for the new Gallant implantable cardioverter-defibrillator (ICD) and CRT-D […]

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Cardiology CE Mark FDA Cleared Imaging

Acutus Medical Secures FDA Clearance, CE Mark for SuperMap™ and Announces First Procedures in U.S. and Initial Experience in EU

Breakthrough Technology Enables Super-Fast Electrical Mapping and Re-Mapping of the Entire Heart Chamber – Leading […]

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CE Mark Neuro Vascular

Cerus Endovascular receives CE mark approval for its Contour Neurovascular System to treat intracranial aneurysms

Cerus Endovascular has received CE mark approval for its lead product, the Contour Neurovascular System, […]

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CE Mark Robotics Surgery

TransEnterix wins CE Mark for Sehance pediatric indication

TransEnterix (NYSE:TRXC) announced today that it has won a CE Mark for an expanded indication to […]

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Cardiology CE Mark Drug-delivery

BIOTRONIK’s Orsiro Mission Drug-Eluting Stent

BIOTRONIK won the European CE Mark for its Orsiro Mission drug-eluting stent. The device is […]

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CE Mark Drug-delivery FDA

Paclitaxel Controversy Is Causing CE Mark Delays for New Paclitaxel Devices

Tension over stents and balloons that are either coated with or are designed to release paclitaxel […]

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Cardiology CE Mark Structural Heart

Abbott’s Tendyne First Transcatheter Mitral Valve to Win EU Clearance

Abbott just announced that it is the first company to receive European regulatory approval to […]

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CE Mark Sensors

Profusa's wireless, injectable oxygen biosensor nabs CE mark

Three years after Profusa’s biosensor earned the CE mark to measure tissue oxygen levels, its follow-up has […]

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Cardiology CE Mark

Imricor Medical Systems ablation catheter wins CE mark

Imricor Medical Systems today said it won CE mark approval for its Vision-MR Ablation Catheter and […]

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CE Mark Neuro

Percept PC Deep Brain Neurostimulator with BrainSense Cleared in Europe

Medtronic obtained the European CE Mark for its Percept PC neurostimulator that uses smart feedback […]

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Cardiology CE Mark

Hemovent wins CE Mark for mobile heart and lung support device

Hemovent GmbH announced today that it won CE Mark approval for its Mobybox Runner controller for […]

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CE Mark Neuro Urology

Medtronic Wins CE Mark for Rechargeable Sacral Neuromodulation Tech

The sacral neuromodulation market continues to see disruption as Medtronic scores a CE mark for its InterStim […]

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CE Mark Neuro Surgery

Polyganics’ Liqoseal sealant patch wins CE mark approval

Polyganics announced that it is initiating the European launch of its Liqoseal dural sealant patch after […]

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CE Mark Neuro

Medtronic receives CE mark approval for the Percept PC Neurostimulator deep brain stimulation system with BrainSense technology

Medtronic announces the CE mark for Percept PC neurostimulator. It is the only Deep Brain […]

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CE Mark Neuro

BioNess wins CE Mark for StimRouter neuromod system

BioNess announced today that it won CE Mark approval for its StimRouter neuromodulation system indicated for […]

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CE Mark

IRRAS wins renewed CE mark for IRRAflow catheter

IRRAS this week said it won CE mark approval for its IRRAflow catheter. The new […]

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CE Mark Neuro

Aleva Neurotherapeutics receives CE mark for its directSTIM directional Deep Brain Stimulation System and raises US$8 million private equity

Aleva Neurotherapeutics has announced that it has been awarded the CE mark for its flagship […]

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CE Mark Patient Monitoring

Iradimed renews CE mark for MRI-safe patient monitor

Iradimed (NSDQ:IRMD) today said it completed the CE mark renewal process and resumed shipments of its […]

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CE Mark Sensors

World's Smallest Reusable Multi-Vital Wearable Sensor Nabs CE Mark

Campbell, CA-based VivaLNK has received Class IIa medical device CE mark for its multi-vital medical […]

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Cardiology CE Mark

VivaLNK’s Tiny Reusable and Wearable ECG Cleared in Europe

VivaLNK, a Silicon Valley company, won the European CE Mark for its VivaLNK multi-vital medical […]

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CE Mark Surgery

Hologic Renews Focus for Breast Health with CE Mark Extension

Hologic is wasting little time putting the focus back on its breast health offerings. The […]

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CE Mark Women's Health

Hologic wins CE mark approval for implantable tag

Hologic (NSDQ:HOLX) announced that it won an extension of the CE Mark approval for its LOCalizer […]

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CE Mark Imaging

Lunit wins CE Mark for AI-powered chest X-ray software

Medical artificial intelligence company Lunit announced that it won CE Mark approval for its Lunit Insight CXR […]

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CE Mark Robotics Surgery

Avatera Robot Cleared in Europe for Minimally Invasive Laparoscopies

A German company called avateramedical GmbH won European regulatory approval for its avatera robot-assisted, minimally […]

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AI CE Mark Diagnostics

Paige gets CE mark for prostate cancer detection technology

Dive Brief: Paige received CE marks for its digital pathology system and an associated technology […]

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Cardiology CE Mark Structural Heart

Europe allows Edwards' Sapien 3 TAVR system in low-risk patients

Dive Brief: Edwards Lifesciences’ Sapien 3 transcatheter heart valve is now allowed for use in […]

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CE Mark Digital Health Sensors

WaveForm Technologies Inc. Awarded CE Mark Approval for Their Continuous Glucose Monitoring System

Novel CGM System Offers 14 Day Wear, Simple, Virtually Pain-Free Insertion and Minute-to-Minute Glucose Readings […]

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CE Mark

Masimo’s Wireless Radius Capnography System Cleared in Europe

Masimo has announced that it won European regulatory approval to introduce its Radius Capnography system. […]

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Original post by Medgadget

Written by: Cici Zhou

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