Coreline Soft said on Wednesday that its brain hemorrhage image detection and diagnosis assistance software, AVIEW NeuroCAD, obtained approval from the Ministry of Food and Drug Safety (MFDS) under the government’s innovative medical device integrated review and evaluation system.The integrated exam
The Korea Exchange (KRX) held a corporate review committee on Monday and decided to maintain the listing of Dx&Vx on the tech-heavy Kosdaq market.With the decision, Dx&Vx's shares resumed trading on Tuesday.This is the first time in four years since the KRX suspended the trading of the stock in 2019
KoBioLabs said on Tuesday that it has signed a memorandum of understanding (MOU) for a comprehensive business partnership with Kakao Healthcare to develop precision and personalized medicine and nutritional solutions using microbiome technology.Under the MOU, the two companies will enhance user acce
Sky Labs said that CART-ⅠPlus, its ring-type heart rhythm monitoring device, has received approval from the Ministry of Food and Drug Safety to measure blood pressure, too.According to the company, CART-ⅠPlus boasts superior convenience by measuring blood pressure using optical capillary pulse waves
“Cyber security readiness is no longer an option but is now mandated by medical device regulatory bodies driven by the U.S., E.U., and the IMDRF (International Medical Device Regulators Forum).”So said a cyber security expert in an interview with Korea Biomedical Review on the side-lines of KIMES 20
With the Korean biotech industry trying to leave its global footprint, the KIMES conference this year paid attention to this trend and invited many guests to speak on the regulations and clinical environment of some of the biggest medical markets including the U.S., EU, and Australia.The Korea Inter
Samsung Electronics and Samsung Medison said they would unveil up-to-date medical devices and artificial intelligence-based diagnostic aid functions by participating in the 38th Korea International Medical & Hospital Equipment Show (KIMES) at COEX, southern Seoul, from Thursday to Sunday.Samsung Med
The Korea International Medical and Hospital Equipment Show 2023 (KIMES), the largest medical device exhibition in Korea, will kick off its four-day run on Thursday this week, under the theme of "Better Life, Better Future."Hosted by the Korea Medical Devices Industrial Cooperation Association (KMDI
Korea's first heavy ion therapy device which has already been installed at Yonsei Cancer Center in Severance Hospital, obtained approval on Tuesday from the Ministry of Food and Drug Safety (MFDS) to treat patients with intractable cancers.The import item license was granted to DK Medical Systems fo
Osteonic said it will supply $4.8 million of its orthopedic implant products to Saudi Arabia's National Unified Procurement Company (NUPCO).According to the company, Arab East Medical, its local partner and exclusive distributor in Saudi Arabia, participated in and won a tender opened by NUPCO.NUPCO
CG Bio said it has opened NULOOK, a medical aesthetics clinic on Bali Island, Indonesia, with plans to make it a medical tourism hub in Southeast Asia.NULOOK will provide comprehensive aesthetic procedures based on bio-medical technology by positioning itself as a place where people can experience h
Medical IP said on Monday that it signed a mutual agreement with Amazon Web Services (AWS) to help advance its cloud-based digital transformation toward global markets using AWS' cloud infrastructure such as the U.S., China, and the Middle East.Per the agreement, AWS will support the smooth implemen
Juvic, a microneedle drug developer, said on Monday that it successfully developed a new drug delivery stamp technology called a micro-pillar tunnel stamp (MPTS) that can significantly improve the drug delivery of existing topical drug formulations.Juvic’s research team, led by Professor Jung Hyung-
3BIGS, a Korean company specializing in medical big data, said on Thursday that it has developed an early version of 3X-GPT which is specialized in mining biomedical data using OpenAI’s interface, ChatGPT.ChatGPT is a natural language processing AI-based chatbot developed by OpenAI which has been dr
Wells Bio said on Wednesday that its careGENE SFTS Virus RT-PCR kit obtained domestic approval to diagnose severe fever with thrombocytopenia syndrome (SFTS) virus.The kit diagnoses the genes of the SFTS virus in human blood samples with real-time reverse transcription polymerase chain reaction (RT-
Medical IP said Tuesday it obtained a second-class medical device certification from the Ministry of Food and Drug Safety for its medical image analysis software, TiSepX Lung Volumetry, which calculates lung volume using chest X-rays.TiSepX is the abbreviation for tissue separation from X-ray. It is
Lunit said it has completed validation of Lunit Scope PD-L1, its artificial intelligence pathology analysis solution, in Clinical Laboratory Improvement Amendments (CLIA)'s laboratory-developed test (LDT).The company conducted the test at Guardant Health's CLIA Lab. According to the joint research a
Macrogen, a Korean genome analysis company, said it installed NovaSeq X Plus, Illlumina’s latest production-scale sequencer, for the first time in Korea.Macrogen plans to complete the introduction and installation of five NovaSeq X Plus devices at its Korea Genome Center, Japanese subsidiary, Europe
Coreline Soft, a company specializing in medical AI solutions, said on Friday that its AI-based lung nodule detection solution, AVIEW Lung Nodule CAD, has obtained FDA 510(k) clearance.This is the first AI-based lung nodule detection CAD in Korea and the fifth in the world to obtain U.S. FDA 510(k)
Kakao Healthcare made clear that it has no plans to jump into the non-face-to-face treatment business in the domestic market even after it is introduced in Korea. However, the company left open the possibility of global business.“We’ve been asked frequently since last year whether Kakao Healthcare w