CE Mark MedTech Neuro

Balt receives CE mark and for its Silk Vista flow diverter

Released on July 9, 2020

Balt has received CE mark approval for its Silk Vista flow diverting stent to treat patients with unruptured intracranial aneurysms, in […]

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Cardiology CE Mark FDA Cleared

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

Released on July 8, 2020

Dive Brief: Medtronic on Tuesday said it received FDA 510(k) clearance and CE marking for its Linq II insertable cardiac monitor that […]

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CE Mark

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

Released on July 7, 2020

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

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CE Mark Implantables Ophthalmology

Staar Surgical launches presbyopia correcting lens

Released on July 7, 2020

Staar Surgical (NSDQ:STAA) announced today that it received CE Mark approval for its EVO Viva presbyiopia-correcting implantable Collamer lens (ICL). Lake Forest, […]

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AI CE Mark Neuro

Study shows novel AI technology is better predictor of stroke than traditional methods

Released on July 2, 2020

Boston-based medical technology company Elucid Bio, maker of the Food and Drug Administration (FDA)-cleared and CE-marked vascuCAP software, announced Wednesday, July […]

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Cardiology CE Mark Vascular

Kardium lands CE Mark for mapping and ablation device

Released on July 1, 2020

Kardium announced that it received CE Mark approval in Europe for its Globe mapping and ablation system for treating atrial fibrillation (AF). […]

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CE Mark Digital Health Neuro

Akili wins CE mark for digital ADHD treatment

Released on June 23, 2020

Akili Interactive announced today that it received CE Mark approval for its EndeavorRx video game for children with attention deficit hyperactivity disorder […]

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Cardiology CE Mark Structural Heart

Medtronic Moves the Needle in TAVI with New Indication

Released on June 23, 2020

Medtronic has received CE mark for an expanded indication of its Evolut Transcatheter Aortic Valve Implantation system. The Dublin-based company said […]

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Cardiology CE Mark Structural Heart

Medtronic Evolut TAVR system gets expanded label in Europe

Released on June 23, 2020

Dive Brief: Medtronic’s Evolut transcatheter aortic valve implantation system now has an expanded CE mark to treat patients with severe aortic […]

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Cardiology CE Mark Structural Heart

Medtronic wins CE mark for TAVI system in low-risk patients

Released on June 22, 2020

Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system. Evolut TAVI, now […]

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CE Mark Implantables Orthopedic

Smith & Nephew Regeneten bioinductive implant wins CE mark

Released on June 17, 2020

Smith & Nephew (NYSE:SNN) announced today that its Regeneten bioinductive implant for rotator cuff procedures received CE Mark approval in Europe. Regeneten, […]

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CE Mark Imaging Oncology

Sirius Medical wins CE mark for non-radioactive localization system

Released on June 17, 2020

Sirius Medical announced that it received CE Mark approval for its Sirius Pintuition non-radioactive tumor localization system. Eindhoven, the Netherlands-based Sirius said […]

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