Cardiology CE Mark

BioCardia wins CE Mark renewal for Helix, Morph catheters

Released on October 10, 2019

BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter […]

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CE Mark MedTech

Minimally Invasive System Aims to Relieve Symptoms for Patients with Chronic Bronchitis

Released on October 9, 2019

“Imagine somebody that gets bronchitis every day, with a cough so severe that they can’t talk in full sentences, they can’t […]

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Cardiology CE Mark

CE mark granted to the Gore Cardioform ASD Occluder for the treatment of atrial septal defects

Released on October 4, 2019

The Gore Cardioform Occluder for atrial septal defects (ASD) has received CE mark in Europe, the company has announced, stating that […]

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Cardiology CE Mark Digital Health

Fitbit and CE-marked software firm announce heart monitoring tie-up

Released on September 30, 2019

Fitbit and health screening and monitoring app FibriCheck, has announced a partnership enabling users in Belgium, the Netherlands, Ireland and the UK […]

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CE Mark Diagnostics MedTech

EU changes for IVDs called a ‘sea change,’ revolutionary

Released on September 23, 2019

Much of the talk around the incoming EU medtech rules has focused on device makers scrambling to prepare. But the new […]

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Cardiology CE Mark

Abbott wins CE Mark for pediatric heart devices

Released on September 18, 2019

Abbott (NYSE:ABT) said today that it won CE Mark approval for its Masters HP mechanical heart valve and Amplatzer Piccolo occluder. The […]

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CE Mark FDA Cleared Neuro

Wallaby Medical wins FDA nod, CE Mark for Avenir neurovascular coil

Released on September 16, 2019

Wallaby Medical announced yesterday that it won FDA 510(k) clearance and CE Mark approval in the European Union for its Avenir coil […]

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CE Mark Spine

Saluda Medical Announces European Commercial Launch of Evoke®, the First and Only ECAP-Controlled, Closed-Loop SCS System for Chronic Pain Relief

Released on September 16, 2019

­­­­ARTARMON, Australia, Sept. 16, 2019 /PRNewswire/ — Saluda Medical Pty Limited (“Saluda Medical”) today announced the award of CE Mark and the European commercial launch […]

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CE Mark

Exact Imaging wins CE Mark for transperineal needle

Released on September 11, 2019

Exact Imaging today said it received CE Mark approval for its Sterile Transperineal Needle Guide for use with its EV29L transducer. The […]

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Cardiology CE Mark

Pacemaker-Like Implant Cleared in Europe to Lower Blood Pressure

Released on September 4, 2019

Orchestra BioMed, a company out of New Hope, Pennsylvania, won the European CE Mark of approval for the Moderato implantable pulse […]

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Cardiology CE Mark FDA

Six-lead personal heart monitoring device launched in the UK

Released on September 2, 2019

AliveCor has launched of KardiaMobile 6L in the UK, an FDA-cleared and CE-marked, six-lead personal heart monitoring device. This smartphone-based technology […]

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CE Mark Robotics

Restoration Robotics lands CE Mark for hair restoration system

Released on August 20, 2019

Restoration Robotics (NSDQ:HAIR) said it has received CE Mark approval for the sale of the Artas iX system designed forf hair restoration…

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