Otsuka Pharmaceutical Co. Ltd. and Ai-Brainscience Inc. signed an exclusive sales agreement for Japan that will see Otsuka market Ai-Brainscience’s eye-tracking application to test for cognitive function. The eye-tracking app, AiBS-01, could become the first dementia diagnosis application to receive regulatory approval in Japan. Ibaraki, Japan-based Ai-Brainscience (AiBS) is developing devices that use the eye-tracking based cognitive assessment test to detect early dementia beyond the conventional assessment methods performed by specialists.
Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020.
After listing on the Nasdaq market on May 18, Hong Kong-based diagnostics and genetic testing company Prenetics Group Ltd. saw its shares fall nearly 30% in early trading, dropping from $8.40 per share on listing to $5.70 by the end of trading May 19. Trading under the ticker PRE, Prenetics formed a merger with Artisan Acquisition Corp., a special purpose acquisition company, which was founded by entrepreneur Adrian Cheng. The transaction values Prenetics at an enterprise value of $1.25 billion, making the company the first Hong Kong unicorn to list on the Nasdaq.
Shanghai Heartcare Medical Technology Corp. Ltd. received marketing approvals for three medical devices designed for stroke, namely its left atrial appendage (LAA) occluder, the aspiration catheter, and the support catheter.
Computational disease modeling company Cytoreason Ltd. is expanding its reach into Asia with a recent partnership with South Korean big data company Helixrus Inc., which is focused on biological big data and multiomics. The alliance will focus on leveraging Helixrus’ deep knowledge of the South Korean pharmaceutical market, and extensive network of relationships in Asian markets, to highlight Cytoreason’s capabilities in prioritizing new targets, finding biomarkers, profiling combinations, stratifying patients and other use cases within the drug lifecycle.
A team at South Korea’s Gwangju Institute of Science and Technology (GIST) developed a new technique to easily visualize viruses using an optical microscope.
The NMPA approved two different surgical robots for marketing, a step forward in growth of a sector that remains underdeveloped in China. One of the robots approved for marketing by the NMPA is from Yuanhua Orthopedic Robotic Ltd. and the other is Suzhou Microport Orthobot Co. Ltd. Both robots are used for total knee arthroplasty (TKA), removing damaged cartilage and bones from the surface of the knee joint and replacing them with artificial implants.
With one-quarter of China’s population affected by rolling shutdowns, manufacturers worldwide are preparing for a summer of supply chain nightmares. Shanghai and its normally bustling port have been closed now for a month and the nation’s COVID-Zero policy is now threatening Beijing. So far, though, the med-tech industry remains minimally affected, but the coming months may tell a different story.
Venus Medtech (Hangzhou) Inc.’s Venusp-Valve, a transcatheter pulmonic valve replacement (TPVR) system, has gained the CE mark in Europe. The system is used to treat moderate to severe pulmonary regurgitation with or without right ventricular outflow tract stenosis. The TPVR provides an alternative for those not eligible for open-chest operations because of the risks such as large trauma, and slow recovery, a spokesperson of Venus Medtech told BioWorld.
Metabolic health platform Ultrahuman Healthcare Ltd. has acquired consumer wearable company Lazy Design Pvt Ltd. India (known as Lazyco) to expand the biomarkers complementing its current wearable, the Ultrahuman M1.
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