CE Mark Vascular

GMED Reinstates CE Mark for Endologix Nellix System

Released on June 7, 2019

The Irvine, CA-based company said its CE mark for the Nellix EndoVascular Aneurysm Sealing System has been reinstated…

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CE Mark FDA Approved Robotics

ReWalk Exo-Suit Gets Green Light in U.S., Europe to Aid Stroke Recovery

Released on June 5, 2019

ReWalk Robotics, a company with offices in Marlborough, Massachusetts and Yokneam Ilit, Israel, won…

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Cardiology CE Mark

Tempo Lead Temporary Heart Trans-Surgical Pacing Lead Cleared in EU

Released on May 8, 2019

BioTrace Medical, a small company headquartered in Menlo Park, California, announced that its Tempo Lead temporary intracardiac pacing lead has been cleared in…

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Cardiology CE Mark

SentreHEART Wins EU Clearances for LARIAT LAA Closure System

Released on May 8, 2019

SentreHEART, based in Silicon Valley, won the…

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CE Mark Structural Heart

SentreHeart wins CE Mark, expanded indications for Lariat LAA devices

Released on May 3, 2019

SentreHeart said that it is currently engaged in a prospective…

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CE Mark FDA Approved

AcQMap Heart Mapping Technology Gets EU and US Green Lights

Released on April 29, 2019

Acutus Medical, a Carlsbad, California company, won European approval for its…

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CE Mark Vascular

Guerbet’s SeQure and DraKon Peripheral Microcatheters Cleared in Europe

Released on April 26, 2019

Guerbet, a French firm, won European regulatory approval to introduce its SeQure and DraKon…

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CE Mark Gastroenterology

SafeHeal wins CE Mark approval for bypass sheath

Released on April 12, 2019

SafeHeal recently announced that it has won CE Mark approval for its …

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CE Mark Surgery

Butterfly iQ Multi-Purpose Pocket-Sized Ultrasound Now Available in Europe

Released on April 10, 2019

Butterfly Network, a company based in Connecticut, finally won the…

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CE Mark Surgery

Primequal wins CE Mark for surgical injection solutions

Released on April 9, 2019

Primequal announced that it has received CE Mark approval for its…

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CE Mark Vascular

Pursuit Vascular wins CE Mark for ClearGuard HD caps

Released on April 4, 2019

Pursuit Vascular announced that it has received CE Mark approval and Medical Device Single Audit Program certificates…

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CE Mark Structural Heart

FEops wins CE Mark approval for HeartGuide

Released on April 3, 2019

HeartGuide is a procedure planning technology that is used for …

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