i-SENS said it has received the regulatory approval for CareSens Air, the first locally-developed continuous glucose monitoring (CGM) device, on Tuesday. CareSens Air is also the fourth CGM product approved in Korea after those by Medtronic, Abbott, and Dexcom.A continuous glucose monitor (CGM) is a
ChatGPT, once a "novelty chatbot," has emerged as the inevitable future of healthcare. Some say generative AI will "replace doctors," but most experts counter that AI technology still needs human interaction to be used properly.Generative AI lives up to its name by "creating" something that doesn't
GI Biome said on Wednesday that it signed a memorandum of understanding (MOU) with two digital healthcare companies, InHandPlus and GI VITA, to jointly develop a decentralized clinical trial (DCT) platform to accelerate the global market entry of GB-X01, an anticancer microbiome pipeline.According t
Medical IP, a company specializing in digital twin-based AI solutions, said on Wednesday that it obtained the FDA 510(k) certification for DeepCatch, an AI software for analyzing CT-based whole-body composition.DeepCatch is a product that segments human body components from CT images and automatical
Korean AI-backed medical imaging companies, which previously faced sluggish stock prices since their listing on the tech-heavy Kosdaq market, are witnessing signs of revitalization this year as share prices sharply rise.Continuing their upward trend, the stock prices of leading domestic medical AI c
Electroceutical, a medical device that aims to achieve therapeutic effects by directly stimulating electric current to the human body, is emerging as a new growth engine for Korean biopharmaceutical companies.In Korea, electroceuticals are classified as medical devices and are subject to approval un
“Hi, Grandma. How’s that uncomfortable feeling in your stomach?”“I took the drug a doctor gave me last time, but I still feel nauseous and uncomfortable.”“It seems appropriate to go back to the doctor.”This conversation is an edited version of the process of managing the health of older adults livin
Seegene said it has signed a technology-sharing agreement with Werfen, the leading diagnostic company in Spain, to begin development discussions on customized products for Spain and Portugal.Under the accord, Seegene will share its syndromic quantitative polymerase chain reaction (PCR) technology.Th
HELSINKI -- By Marianne Chang/Korea Biomedical Review correspondent -- Despite decades of innovation in healthcare with AI solutions and digital therapeutics (DTx), the adoption of these technologies in clinical spaces is still lagging, experts said.In particular, an AI-based solution developed to q
Aptamer Sciences said on Friday that it has officially started non-reimbursed testing of AptoDetect-Lung, a blood-based early detection kit for lung cancer, at tertiary hospitals.Aptamer Sciences has been conducting multi-center prospective clinical trials for health insurance enrollment and securin
Daewoong Pharmaceutical said on Thursday that it signed a contract with digital healthcare start-up, Sky Labs, for the domestic distribution of CART-I BP, a ring-shaped continuous blood pressure monitor, at Daewoong's headquarters in Gangnam-gu, Seoul.Under the agreement, Daewoong Pharmaceutical wil
VUNO, a medical AI company, said Wednesday it has signed a business agreement with medical content platform company Weknew to develop a patient-centered healthcare industry using artificial intelligence.Under the agreement, the two companies will jointly develop various medical content targeted at p
The Ministry of Food and Drug Safety has decided to recognize real-world evidence (RWE) as clinical data in the approval process for digital technology-based medical devices.The ministry said Thursday that it has revised the “Regulation on approving, reporting, and screening medical equipment” to re
Coreline Soft, a company specializing in medical artificial intelligence (AI) solutions, said on Friday that it has received preliminary listing approval from the Korea Exchange (KRX).The company plans to debut on the tech-heavy Kosdaq market in the second half of this year, through Shinhan No. 7 Pa
Ybrain said on Thursday that it participated in the update of the global industry standard guidelines for limited output transcranial electrical stimulation (LOTES).LOTES-2023 is an updated version of LOTES-2017 which is an international standard used in the field of brain stimulation worldwide and
Genomictree, a company specializing in biomarker-based cancer diagnostics, said on Wednesday that it launched its bladder cancer diagnostic product, EarlyTect-BCD, in the U.S.Accordingly, the launch will be carried out by Promis Diagnostics, a U.S. subsidiary of Genomictree, as a laboratory develope
“Since the outbreak of the Russia-Ukraine war, the global supply of medical devices has been disrupted. Developing scarce medical devices that can be produced domestically is crucial. The government must provide opportunities for domestic medical equipment makers through post-approval evaluation ins
Decentralized clinical trials (DCT) drew attention by playing a central role in developing Covid-19 vaccines.DCT is a new clinical trial technique attracting attention worldwide for its advantages compared to traditional clinical trials, such as easy patient recruitment, the convenience of conductin
In an era marked by groundbreaking advancements in genomics sequencing and precision medicine, Illumina Intercontinental is playing a pivotal role. With its cutting-edge next-generation sequencing (NGS) technologies and global presence, Illumina continues to revolutionize the field of genomics.At th
Medtronic said it has entered into definitive agreements to acquire EOFlow, a Korean company specializing in wearable insulin pumps, and announced its intention to delist the company from the tech-heavy Kosdaq market.Under the definitive agreements, Medtronic will acquire all of the shares held by t