Dentis said Wednesday that it has obtained approval from the U.S. Food and Drug Administration (FDA) for its sheet used for clear orthodontic device, “Serafin.”“MESHEET,” developed by Dentis, is a dental orthodontic sheet with a composite structure embedded with a mesh-structured cushioning mat, and
Kakao Healthcare said over 50 health regulatory officials, including those from the Ministry of Food and Drug Safety, the WHO, and the U.S. FDA, visited its headquarters on Monday in light of the AI Regulatory and International Symposium 2024 (AIRIS 2024).The event is ongoing at the Shilla Seoul Hot
CG Bio said it has become the largest shareholder in Innosys, a research and manufacturing company focused on orthopedic implants, following the completion of an equity acquisition on Tuesday.The acquisition involved CG Bio finalizing share transfer agreements for a 17.75 percent stake in Innosys an
JW Medical said Thursday that it launched the ARIETTA 750 DeepInsight (AR750DI), a premium ultrasound imaging device incorporating high-resolution image-realizing technology.Developed by Japan’s Fujifilm, AR750DI is a premium ultrasound medical device that applied Deep Insight technology to the exis
As tensions between the U.S. and China in the healthcare industry escalate, the U.S. is intensifying its scrutiny of Chinese companies, extending beyond the biotech sector into medical devices.The U.S. FDA has recently issued a warning to medical device manufacturers to re-examine the work of third-
Boditech Med said Wednesday that it has acquired a 3.03 percent stake in 4TEEN4 Pharmaceuticals GmbH (4TEEN4), a German company focusing on developing therapeutics and diagnostic biomarkers for treating cardiogenic shock.Along with the equity investment, Boditech Med has entered into a license agree
MediThinQ, a company focusing on medical augmented reality (AR) technology, has announced a strategic partnership with Medtronic to introduce the AR wearable display, Scopeye, into the U.S. market.At a press conference on Wednesday, MediThinQ CEO Im Seung-joon detailed the collaboration's objectives
The government has announced a plan to use non-face-to-face medical treatment as a countermeasure to the collective action of the medical community, but related companies said they have never heard about it.At the “Ministerial Meeting on Response to Collective Action” on Monday, Prime Minister Han D
The Ministry of Food and Drug Safety announced a three-month manufacturing suspension for Celltrion Pharm's Astection Enteric Coated Tablets 100mg (aspirin), effective from Feb. 27 to May 26, due to violations of the Pharmaceutical Affairs Act.The medication is used for preventing thrombosis in cond
Innovative medical device companies have continued to record sales growth despite the challenges posed by Covid-19. These companies also increased new investment and R&D spending after becoming certified as innovative medical device companies, demonstrating the positive effects of the “innovative me
Humedix, a Kosdaq-listed healthcare firm, said Monday that its board of directors has recently decided to pay cash dividends.The final cash dividend per share will be 275 won ($0.2), representing 10.39 million shares. The company said the total amount of cash dividend for the year is 2.85 billion wo
Seegene, once hailed as a beneficiary of the Covid-19 pandemic, has reported a significant deterioration in profitability due to a drastic decline in related sales as the world transitions to the endemic phase of the virus.The company announced its preliminary financial results for 2023 last Friday,
Medical AI company Lunit said Monday that a research paper that predicted immunotherapy's effectiveness using Lunit SCOPE IO, an AI biomarker platform, has been published in the Journal for Immunotherapy of Cancer (JITC), the official journal of the Society for Immunotherapy of Cancer (SITC).Founded
VUNO said it has entered into a strategic partnership with DRGEM to embed VUNO's advanced AI solutions into DRGEM's X-ray systems.Under the agreement, VUNO will supply its AI-based thoracic X-ray interpretation assistant solution, VUNOMED Chest X-ray, to DRGEM.VUNOMED Chest X-ray stands out as an AI
Lunit announced a record-breaking revenue of 25 billion won ($21 million) for 2023, marking an 80.9 percent increase from 13.8 billion won a year earlier, thanks to a continued expansion of overseas sales of medical AI solutions. Last year, the Kosdaq-listed company posted an operating loss of appro
LifeSemantics said Thursday that it has completed the confirmatory clinical trial of its skin cancer image detection and diagnostic assistance software, a medical artificial intelligence solution that detects skin cancer.The clinical trial was a multi-center, retrospective study to prove the clinica
With the establishment of a new medical device category for lubricating gels, regulators are now outlining test methods to guide its evaluation.The Ministry of Food and Drug Safety (MFDS) said Wednesday that it has published and distributed the “Information Sheet on Test Methods for Personal Lubrica
VUNO, a Korean medical AI company, said Wednesday that its research on a self-supervised learning (SSL) algorithm to improve the efficiency and accuracy of artificial intelligence-based ECG data analysis has been adopted by the International Conference on Learning Representations (ICLR).ICLR, now in
Neurophet and ReadyCure said they have signed a business agreement to exchange business and conduct projects related to developing an Alzheimer's disease treatment.Under the accord, Neurophet will cooperate on developing ReadyCure's upcoming dementia treatment medical device, Helaxon.Utilizing its a
Waycen, a medical AI company, said Monday that it has been certified as the “No. 7 Innovative Medical Device Software Manufacturer” by the Ministry of Food and Drug Safety (MFDS).Waycen won the certification for its continuous quality management efforts, including product development, verification,