CE Mark Sensors

World’s Smallest Reusable Multi-Vital Wearable Sensor Nabs CE Mark

Released on December 3, 2019

Campbell, CA-based VivaLNK has received Class IIa medical device CE mark for its multi-vital medical wearable sensor and software development kit. […]

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Cardiology CE Mark

VivaLNK’s Tiny Reusable and Wearable ECG Cleared in Europe

Released on December 3, 2019

VivaLNK, a Silicon Valley company, won the European CE Mark for its VivaLNK multi-vital medical wearable sensor and accompanying software development […]

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CE Mark Surgery

Hologic Renews Focus for Breast Health with CE Mark Extension

Released on December 2, 2019

Hologic is wasting little time putting the focus back on its breast health offerings. The Marlborough, MA-based company received an extension […]

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CE Mark Women's Health

Hologic wins CE mark approval for implantable tag

Released on November 30, 2019

Hologic (NSDQ:HOLX) announced that it won an extension of the CE Mark approval for its LOCalizer radiofrequency identification (RFID) tag for long-term […]

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CE Mark Imaging

Lunit wins CE Mark for AI-powered chest X-ray software

Released on November 25, 2019

Medical artificial intelligence company Lunit announced that it won CE Mark approval for its Lunit Insight CXR up-to-date chest X-ray analysis AI. The […]

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CE Mark Robotics Surgery

Avatera Robot Cleared in Europe for Minimally Invasive Laparoscopies

Released on November 19, 2019

A German company called avateramedical GmbH won European regulatory approval for its avatera robot-assisted, minimally invasive surgical system. The CE Mark […]

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AI CE Mark Diagnostics

Paige gets CE mark for prostate cancer detection technology

Released on November 13, 2019

Dive Brief: Paige received CE marks for its digital pathology system and an associated technology for detecting prostate cancer, the company […]

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Cardiology CE Mark Structural Heart

Europe allows Edwards’ Sapien 3 TAVR system in low-risk patients

Released on November 6, 2019

Dive Brief: Edwards Lifesciences’ Sapien 3 transcatheter heart valve is now allowed for use in Europe in patients at low risk […]

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CE Mark Digital Health Sensors

WaveForm Technologies Inc. Awarded CE Mark Approval for Their Continuous Glucose Monitoring System

Released on November 6, 2019

Novel CGM System Offers 14 Day Wear, Simple, Virtually Pain-Free Insertion and Minute-to-Minute Glucose Readings Transmitted Directly to Smartphone WILSONVILLE, Ore., Nov. […]

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CE Mark

Masimo’s Wireless Radius Capnography System Cleared in Europe

Released on November 1, 2019

Masimo has announced that it won European regulatory approval to introduce its Radius Capnography system. The product is a portable real-time […]

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CE Mark Women's Health

In Vivo Incubation System Cleared in Europe for More Natural IVF

Released on October 30, 2019

INVO Bioscience, a Florida company, has just won European regulatory approval for its INVOcell culture and retention device. The product is […]

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Biotech CE Mark

Invo Bioscience wins CE Mark for InvoCell fertility device

Released on October 29, 2019

INVO Bioscience (OTCQB:IVOB) said last week that it received CE Mark approval for its InvoCell culture and retention device as an alternative […]

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