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- Unique dense breast tissue focus to drive expedited recruitment rates; modular clinical study design reduces time to PMA submission by ~6 months - - 3 Site U.S.-based clinical study enables early data collection to kickstart European CE Mark Application - - Company to announce development of 2 new medical imaging devices in the next 12 months to trigger momentum and increase valuation during clinical data collection phase -

Lunit (KRX:328130.KQ) today announced that its AI solution for 3D Breast Tomosynthesis (DBT) analysis, Lunit INSIGHT DBT, has met the requirements of the CE marking under Europe’s latest Medical Device Regulation (MDR).

Senseonics Holdings, Inc. announced that it has received CE Mark approval for the next-generation Eversense® E3 CGM System, the longest-lasting system available, with exceptional accuracy.

Acutus Medical, Inc. today announced receipt of a CE Mark issued under the European Union (EU) Medical Device Regulations (MDR) for its AcQMap 3D Imaging and Mapping Catheter, the world’s only integrated high-resolution ultrasound imaging and non-contact mapping catheter.

iCAD, Inc., a global medical technology leader providing innovative cancer detection and therapy solutions, announced that ProFound AI® Version 3.0 for Digital Breast Tomosynthesis received CE Mark approval.

Aetrex Worldwide, Inc. (“Aetrex”), the global leader in foot scanning technology and orthotics, is showcasing Albert 2, the next generation of the company’s revolutionary 3D foot scanner, at CES 2021. Albert 2 combines

Catalyst Clinical Research announced today that it has merged with Ce3, Inc . to expand its depth of oncology-specific therapeutic expertise. The combined company is strongly positioned to deliver oncology clinical development services to the biotechnology industry, as Ce3 has provided such services for more than 15 years. Catalys

QualiMed Innovative Medizinprodukte GmbH, a wholly owned subsidiary of Dublin, Ireland based Q3 Medical Devices Limited (Q3), announced that it has received CE mark approval for a dedicated percutaneous biodegradable metal alloy based stent implant for biliary applications, the UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent (BEBS)

Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3™ Cerebral Embolic Protection (CEP) Device

On schedule with CES 2020, pmdtechnologies is presenting its latest 3D Time-of-Flight camera module, based on the 5th generation REAL3™ ToF image sensor from pmd and Infineon: The IRS2877C with VGA resolution depth data output and a newly designed 5µm pmd pixel core.