approval Archives | Be Korea-savvy
Samsung’s Blood Pressure Monitoring App Earns Medical Device Approval in S. Korea

Samsung’s Blood Pressure Monitoring App Earns Medical Device Approval in S. Korea

SEOUL, April 21 (Korea Bizwire) — Samsung Electronics Co. said Tuesday its blood pressure monitoring mobile application has earned medical device approval in South Korea. The Ministry of Food and Drug Safety has granted the Software as a Medical Device (SaMD) license to its health monitoring app, according to Samsung. The software leverages a smartwatch’s [...]

S. Korea’s First For-profit Hospital Gains Approval from Jeju Provincial Gov’t

S. Korea’s First For-profit Hospital Gains Approval from Jeju Provincial Gov’t

JEJU, Dec. 5 (Korea Bizwire) — South Korea’s first for-profit hospital received the final approval from the Jeju Special Self-Governing Province on Wednesday, putting an end to 16 years of controversy over the introduction of investor-owned medical institutions. Jeju Gov. Won Hee-ryong announced the approval of the Greenland International Hospital as a for-profit hospital on [...]

Celixir Announces US FDA Approval of the IND Application for Cell Therapy Heartcel

Celixir Announces US FDA Approval of the IND Application for Cell Therapy Heartcel

Stratford-upon-Avon, UK, Jun. 8 (Korea Bizwire) – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell therapy for the treatment of adult heart failure. Celixir announced in January the approval [...]

Samsung Bioepis Gets Nod for Biosimilar Drug in Europe

Samsung Bioepis Gets Nod for Biosimilar Drug in Europe

SEOUL, Aug. 25 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Friday it has won approval from European authorities for the sale of its biosimilar drug Imraldi. The European Commission (EC) accepted Samsung Bioepis’ application to sell the biosimilar referencing AbbVie Inc.’s Humira, the company said in a regulatory filing. The drug [...]