CE Mark MedTech

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

Released on April 6, 2020

Received CE Mark for its first sterile biodegradable sealant in a pre-filled syringe format Issuance of new certifications from TÜV SÜD […]

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CE Mark Orthopedic Spine

SpineGuard receives CE mark for DSG Connect platform

Released on April 2, 2020

SpineGuard has announced that it has received the CE mark for the commercial release of its DSG Connect platform. Already being […]

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Cardiology CE Mark Respiratory

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

Released on April 1, 2020

CardioQuip, a firm based in College Station, Texas, won European regulatory approval (CE Mark) for its MCH-1000 cooler-heaters that are used […]

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CE Mark Respiratory

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

Released on March 31, 2020

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

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CE Mark Diagnostics

Thermo Fisher Granted CE Mark for COVID-19 Test

Released on March 26, 2020

Thermo Fisher Scientific is bringing its diagnostic detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19, to Europe. The Waltham, […]

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CE Mark Diagnostics Radiology

EchoNous Receives EU Approval for Kosmos AI Ultrasound Platform

Released on March 23, 2020

EchoNous announced that it has received the European CE Mark of approval for its Kosmos platform, an ultrasound and AI-based software […]

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CE Mark MedTech

French startup Dianosic nets CE Mark for nosebleed-stopping balloon

Released on March 16, 2020

A French startup has received a CE mark for a small, inflatable device designed to apply gentle pressure and halt nosebleeds. […]

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CE Mark Implants Orthopedic

DePuy Synthes wins CE Mark for hip replacement dual mobility system

Released on March 13, 2020

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

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Cardiology CE Mark Neuro

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

Released on March 12, 2020

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

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CE Mark Neuro Structural Heart

Rival to Boston Scientific device used in TAVR wins CE mark

Released on March 11, 2020

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

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Cardiology CE Mark Digital Health

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

Released on March 11, 2020

Biobeat announced recently that it has received CE Mark approval for its patch and wristwatch that non-invasively measure blood pressure, cardiac […]

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Dianosic lands CE Mark for intranasal bleeding device

Released on March 10, 2020

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

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