'Medical AI' Coreline Soft Obtains European CE MDR Certification

Coreline Soft, a medical artificial intelligence (AI) development company, announced on the 28th that it has obtained the European CE MDR certification. This certification was achieved as the first AI medical device software at the llb level. It is also explained that this is the first case in Korea to receive such certification for diagnostic purposes. Coreline Soft also obtained certification through the new UK Conformity Assessed (UKCA) system in the United Kingdom, which has withdrawn from the European Union (EU).

Kim Jin-guk, CEO of Coreline Soft (left), is holding the European MDR CE certificate and posing for a commemorative photo at the 'European Certification Award Ceremony' held on the 25th at Coreline Soft headquarters in Mapo-gu, Seoul.
[Photo by Coreline Soft]

CE MDR is an international medical device regulation that must be complied with to enter the European market. It replaced the existing Medical Device Directive (MDD) and was implemented in May 2021. Unlike the previous system, it has legal binding force and strengthens product safety and quality systems through stricter evaluation procedures, management, control, and post-market surveillance, thereby providing higher reliability.

With the acquisition of this MDR, Coreline Soft can now sell its AI product line, AVIEW, throughout Europe, including the 27 EU countries. Specific products include ▲ AVIEW LCS, an automatic lung nodule analysis software, ▲ AVIEW COPD, an automatic chronic obstructive pulmonary disease analysis software, ▲ AVIEW CAC, an automatic coronary artery calcification diagnosis software, which are existing products in the chest field, as well as ▲ AVIEW NeuroCAD, a brain hemorrhage diagnosis support software,

and ▲ AVIEW BAS, a brain vascular imaging visualization software.

Jinkook Kim, CEO of Coreline Soft, said at the European certification awarding ceremony, "We will continue to invest to establish ourselves as a leading company in the field of lung cancer diagnosis in the European market," adding, "With this CE MDR and UKCA certification, we expect to gain momentum in lung cancer screening projects rapidly progressing in major countries."