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Saved

Topic: CE Mark

article icon article
CE Mark MedTech

Nuwellis wins CE mark for 24-hour blood circuit set for use with Aquadex SmartFlow

Nuwellis (NSDQ:NUWE) announced today that it received CE mark approval for its 24-hour blood circuit set […]

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CE Mark MedTech Spine

ZygoFix receives CE mark for its zLOCK spinal fusion system

ZygoFix has obtained CE mark for its minimally invasive screwless spinal fusion system, called zLOCK, for […]

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AI CE Mark

Viz.ai receives CE mark to bring AI-powered stroke care software to Europe

Viz.ai has been awarded a CE mark for its artificial intelligence (AI)-powered stroke care software, […]

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CE Mark MedTech Spine

NuVasive receives CE Mark for Pulse platform and begins global clinical evaluations

NuVasive has revealed that its Pulse platform received CE Mark approval for its latest design […]

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CE Mark FDA MedTech

Neo Medical lands FDA approval and CE certification for Pedicle Screw System

Neo Medical has received US Food and Drug Administration (FDA) 510(k) clearance for the use […]

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AI CE Mark Neuro

Avicenna.AI receives CE mark for AI tool to assess stroke severity

Medical imaging AI specialist Avicenna.AI has received CE mark certification for its CINA ASPECTS AI […]

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CE Mark FDA Spine

Spinal Stabilization Technologies receives CE Mark and FDA breakthrough designation for PerQdisc Nucleus Replacement System

Spinal Stabilization Technologies (SST) has announced that it has earned the CE Mark and the […]

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CE Mark Drug-delivery Patient Monitoring

Medtronic wins CE mark for smart insulin pen, CGM system

Medtronic (NYSE:MDT) announced today that it received CE mark approvals for its InPen smart insulin […]

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CE Mark Healthcare MedTech

PAVmed wins CE mark for carpal tunnel device

  PAVmed (NSDQ: PAVM) today announced that it has received the CE mark for its […]

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CE Mark MedTech Neuro

Chordate Medical receives CE mark to treat chronic migraine with neuromodulation product

Chordate Medical has received a CE marking that permits its Kinetic Oscillation Stimulation (KOS) technology […]

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Cardiology CE Mark

Abbott’s CE Mark for Navitor is a New Chapter for TAVR

Abbott Laboratories is making some noise in the transcatheter aortic repair/implantation market this week by […]

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CE Mark MedTech Neuro

Perfuze announces CE mark and treats first patients with Millipede 088 catheter

Neurovascular medical device company Perfuze has announced that the first five acute ischaemic stroke patients […]

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CE Mark FDA Cleared Robotics

NovaSignal launches the NovaGuide 2 

NovaSignal has announced the launch of the NovaGuide 2 platform, which provides clinical teams with […]

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AI CE Mark MedTech

AI technology detects ‘ticking time bomb’ arteries

The EU has approved an artificial intelligence (AI) technology that can identify people at risk […]

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CE Mark Patient Monitoring Wearables

Aktiia Optical Blood Pressure Monitor Wins European Green Light

Swiss company Aktiia, whose cuffless blood pressure monitor we’ve been following for several years, announced […]

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CE Mark Diagnostics MedTech

Abbott Wins CE Mark for Asymptomatic and Self-Swabbing COVID-19 Test

Abbott Laboratories has received CE mark for two new uses of its Panbio COVID-19 Ag Rapid […]

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CE Mark FDA Neuro

Boston Sci Wins Nod for 4th Gen. Vercise Genus DBS

Boston Scientific won a nod from FDA for its fourth-generation Vercise Genus Deep Brain Stimulation […]

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CE Mark Robotics Surgery

Distalmotion gains CE Mark for surgical robot

Distalmotion announced that it received CE Mark approval for its Dexter surgical robot for minimally invasive […]

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CE Mark Robotics Surgery

Symani Microsurgical System Cleared in Europe

Medical Microinstruments (MMI), a company based outside of Pisa, Italy, won the European CE Mark […]

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CE Mark Diagnostics Healthcare

Siemens Healthineers projects up to 8% revenue growth in FY2021

Dive Brief: Siemens Healthineers saw year-over-year revenue decline 2% in its most recent fiscal fourth […]

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CE Mark Robotics Surgery

MMI wins CE Mark for robotic microsurgery system

MMI SpA announced today that it received CE Mark for and launched its Symani surgical system […]

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CE Mark Digital Health Patient Monitoring

Abbott’s Tiny Freestyle Libre 3 Cleared in EU

Abbott has received CE Mark approval for the Freestyle Libre 3 continuous glucose monitor, meaning […]

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CE Mark MedTech Surgery

Surgical Innovation Associates gains CE Mark for absorbable mesh

  Surgical Innovation Associates announced this week that it has secured CE Mark approval for […]

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CE Mark Drug-delivery MedTech

Abbott Pushes CGM Boundaries with Freestyle Libre 3

Abbott Laboratories has scored a CE mark for the Freestyle Libre 3. The approval in […]

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CE Mark Patient Monitoring Sensors

Abbott scores CE Mark for its first glucose sport biosensor

Abbott announced that its Libre Sense Glucose Sport Biosensor has achieved a CE Mark, paving […]

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CE Mark MedTech

Medical devices sold in Great Britain to require a new UK product safety marking

The UK government has released a proposed regime on the regulation of medical devices in […]

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CE Mark Digital Health Wearables

Withings announces ScanWatch has received medical CE marking

French digital firm Withings today announced that its latest wearable is available in Europe, after […]

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CE Mark Imaging MedTech

Osprey Medical jumps 8% on news of CE Mark

Osprey Medical (ASX:OSP) announced that it received CE Mark approval in Europe for its DyeVert Power […]

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CE Mark Ophthalmology Wearables

eSight Wins CE Mark for Wearable to Enhance Vision

eSight has won CE mark for a wearable assistive technology that can enhance vision for […]

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Cardiology CE Mark Implantables

Endologix Alto Abdominal Stent Graft for AAA Cleared in Europe

Endologix, based in Irvine, California, won clearance in the European Union for its ALTO Abdominal […]

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CE Mark Neuro Vascular

Cerus Endovascular and Balt enter strategic distribution agreement for devices treating intracranial aneurysms

Cerus Endovascular and AB Medica, a subsidiary of Balt, has announced that they have entered […]

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CE Mark Neuro Vascular

CerusEndo MC 021 microcatheter wins CE mark

Cerus Endovascular has announced that it has received CE mark approval for its CerusEndo MC […]

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CE Mark MedTech Neuro Vascular

Rapid Medical’s Tigertriever XL receives CE mark approval

Rapid Medical has announced CE mark approval for Tigertriever XL stentriever. The company noted that […]

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CE Mark Imaging Spine

7D surgical gains CE mark approval for its MvIGS imaging system for spinal surgery

7D Surgical has announced that it has achieved CE mark certification for its Machine-vision Image […]

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CE Mark MedTech Orthopedic

7D Surgical wins CE mark for image guided spinal surgery system

7D Surgical received CE mark certification for its Machine-vision Image Guided Surgery system for spinal […]

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CE Mark MedTech Neuro

Balt receives CE mark and for its Silk Vista flow diverter

Balt has received CE mark approval for its Silk Vista flow diverting stent to treat […]

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Cardiology CE Mark FDA Cleared

Newest Medtronic implantable heart monitor gets FDA nod as remote device features proliferate

Dive Brief: Medtronic on Tuesday said it received FDA 510(k) clearance and CE marking for […]

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CE Mark

EU MDR: Consider Post-Market Clinical Follow-up through End-User Surveys

The EU Medical Device Regulation (EU MDR) is a new and updated set of regulations, following […]

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CE Mark Implantables Ophthalmology

Staar Surgical launches presbyopia correcting lens

Staar Surgical (NSDQ:STAA) announced today that it received CE Mark approval for its EVO Viva presbyiopia-correcting […]

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Original post by MassDevice

Written by: Sean Whooley

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