Wells Bio said on Thursday that it obtained medical device approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for its careSTART G6PD Biosensor Analyzer.Accordingly, the company will begin exporting the device to Japan this month.The biosensor analyzer is a medical device th
The Ministry of Food and Drug Safety (MFDS) said on Thursday that it has designated the Z-med Ⅱ Percutaneous Transluminal Valvuloplasty Catheter, a balloon-expandable valve catheter, as a rare medical device to aid patients who require an aortic valve replacement.Similar to orphan drugs, rare medica
GE HealthCare has recently become an independent entity, having spun off from the larger GE organization. With a focus on precision care, the company aims to improve patient outcomes by integrating segmented care and addressing gaps in healthcare workflows. To achieve this, GE Healthcare utilizes a
T&R Biofab said on Wednesday that its researchers published a paper describing a 3D bioprinting technology capable of printing capillaries within organoids with characteristics similar to those of human organs.Organoids are self-organized 3D tissue cultures derived from stem cells which can replicat
Lotte Healthcare said it has granted stock options to nine executives including CEO Lee Hoon-ki and Executive General Manager Woo Woong-jo.The decision aimed to reinforce the company's position as one of Lotte Group's new growth engines and to further enhance corporate value in the mid-to-long-term
The government announced on Tuesday that it aims to establish Korea as one of the top five medical device export powers by investing 10 trillion won ($7.6 billion) in research and development (R&D) of medical devices between 2023 and 2027, in collaboration with the private sector.In addition, the go
CG Bio said it participated in the Aesthetic and anti-aging Medicine World Congress (AMWC) 2023, an anti-aging conference held in Monte Carlo, Monaco, from March 30 to April 1, and signed supply contracts worth 16.5 billion won ($12.6 million) with Argentina and France. The company said that it sign
Although the Korean medical device market grows rapidly, foreign companies, not domestic firms, take substantive profits, an expert pointed out Monday.Sun Kyung, a special professor at Kyung Hee University, said so during a forum to discuss the innovative growth of medical equipment at the National
Seegene, a South Korean biotechnology company, is teaming up with the International Vaccine Institute (IVI) to conduct tests for human papillomavirus (HPV) on nearly 50,000 people in eight countries across Asia and Africa.Seegene and IVI said they signed a memorandum of understanding (MOU) at IVI's
Shares of Sugentech, an in vitro diagnostics manufacturer, shot up on Monday after the company announced that it "registered" its digital healthcare platform, Surearly SMART, with the U.S. FDA.In the press release, the company said it received FDA approval but Korea Biomedical Review has learned tha
Shares of Bionote have been plummeting non-stop since the company went public on the Kospi market on December 23 last year.As of 2:00 p.m. Friday, the company's shares stood at 6,470 won ($4.99), down 44.7 percent from an all-time high of 11,700 won, recorded on the day of its listing. The company's
Digital healthcare is drawing global attention as the world undergoes the Fourth Industrial Revolution and the Covid-19 pandemic.Korea also stresses the need to develop a digital healthcare industry, but the related market is not growing. According to the Korea Health Industry Development Institute,
LPG Group, a French medical and aesthetic device company, said LPHYSIO, a Korean wellness company specializing in high-end fitness and therapy, will exclusively supply the French company’s medical devices for professional use in Korea.Under the agreement, LPHYSIO will supply LPG Group's professional
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