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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

inHEART, a privately-held medical device company delivering the world’s most advanced digital twin of the patient’s heart, announced that it has received CE certification under the new European Medical Device Regulation for its inHEART MODELS software suite that enables 3D visualization and analysis of anatomical structures for image-guided cardiac ablations.