OSTEOSYS ONE OF THE FIRST TO RECEIVE APPROVAL FOR DXA(Dual-energy X-ray Absorptimetry) SYSTEMS UNDER THE EU MEDICAL DEVICE REGULATION (MDR) CERTIFICATION

August 22, 2024 — SEOUL, KOREA. — OSTEOSYS CO., LTD, a company that manufactures BMD(Bone Mineral Densitometer)s and related software solutions, announced today that OsteoSys is approved under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR.

EU MDR is the European Union Medical Device Regulation 2017/745 that was released in 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.

OsteoSys has now obtained CE marking for all DXA systems (PRIMUS, EXCELLUS, DEXXUM T QUANTUM, DEXXUM T, EXA-3000) under the EU MDR.

“OsteoSys is very proud and pleased to have received MDR certification for DXA BMD systems” said Dr. Youngbok AHN, President of OsteoSys. “EU MDR is the strictest level of European medical regulation for a medical device and represents OsteoSys’s long-standing and outstanding commitment to product quality, safety, and efficacy.”

OsteoSys continues to work diligently toward achieving EU MDR approval and certification for OsteoSys’s full portfolio of products.

About OsteoSys

OsteoSys is a leading company with an 80% share in the domestic bone density DXA device diagnosis market and is expanding its expertise to overseas markets through 150 suppliers in more than 70 countries. From 2018 to 2023, OsteoSys succeeded in winning consecutive tenders for the whole body DXA device by the Turkish Ministry of Health supplying 150 units of whole body DXA system, Primus. As of 2024, the preclinical DXA, iNSiGHT, which had been launched in overseas markets since 2019, has been installed in renowned medical and research institutes such as Harvard Joslin Diabetes Center, National Institutes of Health (NIH), MD Anderson Cancer Center, and Mayo Clinic in the U.S.A. While leading the bone density diagnosis technology not only in Korea but also in overseas markets, OsteoSys is doing the best to achieve its core value ‘better products for better life’ in the medical and research field.

For more information, visit https://osteosys.com/en/