The growing number of people taking up more active sports in China is powering the global market for orthopedic trauma devices through a surge in demand and the emergence of new lines of surgical products, particularly ones that can improve patient outcomes and experience.
The U.S. FDA’s surveillance of duodenoscopes and other endoscopes was initially driven by concerns about device sterility, but recent inspections of manufacturing sites operated by Olympus Medical Systems Corp., in Japan have fed warning letters for lapses from various regulations. In the latest warning letter, the agency cited one of the company’s sites in Tokyo for both quality system and medical device reporting lapses, the second warning letter issued to the company in roughly three months.
Bionicm Inc. completed a funding round on Feb. 13 to speed up development of its powered prosthetic leg products. The round, valued at “tens of millions of yuan,” was led by Nventure Capital, a wholly owned subsidiary of Nec Capital Solutions Ltd.
Japan’s Ministry of Health, Labour and Welfare (MHLW) has given Intuitive Surgical Inc. the green light for its Da Vinci SP surgical system. The surgical system has been cleared for use in general surgeries, thoracic surgeries (excluding cardiac procedures and intercostal approaches), urologic surgeries, gynecological surgeries, and trans-oral head and neck surgeries.
A team of researchers at Toyohashi University of Technology in Japan have come up with a semiconductor sensor that can detect minute traces of biomarkers for infections or diseases.
Pear Therapeutics Inc. partnered with Softbank Corp. to bring a digital therapy for sleep/wake disorders to the Japanese market. Pear will develop the app, while Softbank will evaluate Japanese market potential with an option to negotiate an exclusive license for Pear’s Japanese sleep/wake disorder therapeutics.
Shionogi and Co. Ltd. is looking to become the first company to get approval for a COVID-19 treatment under Japan’s conditional approval system as it prepares a phase III trial for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19.
Japan’s Astellas Pharma Inc. is continuing its investment in gene therapies, following up its $3 billion acquisition of Audentes Therapeutics Inc. with a technology licensing deal with Dyno Therapeutics Inc. potentially worth more than $1.6 billion. Central to the deal is Cambridge, Mass.-based Dyno’s adeno-associated virus (AAV) vector technology, which can be used to direct gene therapies to skeletal and cardiac muscle.
