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
NGeneBio said on Wednesday that it agreed to acquire technology from the Korea Research Institute of Bioscience and Biotechnology (KRIBB) and Konyang University to diagnose and monitor degenerative brain diseases based on liquid biopsy.Accordingly, the company hopes to commercialize the diagnostic p
Novartis Korea said on Tuesday that it launched the “Early Bird” program to support genetic testing for accurate diagnosis and treatment of patients with inherited retinal diseases (IRD).IRD is a progressive disease in which the genes of retinal cells are abnormal at birth, causing various visual im
The Ministry of Food and Drug Safety (MFDS) said on Monday that it designated Nunaps’ virtual reality (VR)-based visual stimulation software as the nation’s 33rd innovative medical device.VIVID Brain is the first product in Korea to improve visual impairment caused by brain damage. Accordingly, it w
The Korea Telemedicine Industry Council (KTIC) has voiced its opposition to the government’s pilot project plan, saying it runs squarely counter to the public’s demand by allowing only second-time treatment in principle.“After all, our concerns have become a reality. The pilot project plan unveiled
Osstem Implant, a Korean dental equipment and supplies manufacturer, confirmed its intention to voluntarily delist from the tech-heavy Kosdaq market.The company said in a public filing on Thursday that it would hold an extraordinary general shareholders’ meeting regarding the delisting issue at its
Representatives of the nation’s largest digital healthcare companies, including Kakao Healthcare, Welt, and Vuno, put their heads together to induce better and more extensive policy support from the government.They did so at a meeting organized by the Ministry of Food and Drug Safety for digital hea
i-SENS, a local in vitro diagnostics company, has acquired AgaMatrix, a U.S. blood glucose measuring device manufacturer.According to a public filing made by the company, i-SENS will acquire 52.57 million shares of AgaMatrix for about 36.1 billion won ($26.9 million). Following the acquisition, i-SE
Major in vitro diagnostic companies in Korea experienced a decline in sales in the first quarter.Among the five listed companies, SD Biosensor reported sales of 182.4 billion won ($136.5 million) in the first quarter of this year, down 7.6 percent from the previous quarter. However, the company redu
Lunit said it is expanding the pilot introduction of AI solutions to overseas deployed troops and medical institutions in combat zones to advance the military medical environment.Lunit recently signed an agreement with the Ministry of Science and ICT and the National IT Industry Promotion Agency (NI
SD Biosensor, an in vitro diagnostic firm, is facing trouble at home and abroad.In April, the National Tax Service slapped a fine of about 100 billion won ($74.6 million) on SD Biosensor, and the U.S. Food and Drug Administration recently recommended suspending the use of the company’s Covid-19 diag
Ybrain, a company specializing in mental health therapeutics, said on Thursday that its depression electroceutical, MINDD STIM, showed significant improvement in a study of Covid-19 patients suffering from brain fog.Brain fog occurs when a person feels depression, fatigue, and cognitive decline and
Lunit's first-quarter consolidated sales hit 10.9 billion won ($8.2 million), marking a remarkable 268.6 percent surge compared to the same period of 2022. The first-quarter revenue, boosted by solid international sales, is nearly 80 percent of the company's total revenue last year.Overseas sales in