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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.

- 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 -

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.

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