The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
Zylox-Tonbridge Medical Technology Co. Ltd. plans to expand globally with M&As, company chairman and CEO Jonathon Zhong Zhao told BioWorld, starting with a stepwise acquisition of Optimed Holding GmbH and its subsidiaries, including Optimed Medizinische Instrumente GmbH.
Rakuten Medical Inc. raised $100 million in a series F round to support late-stage clinical development of ASP-1929, its Alluminox-derived photoimmunotherapy being tested with Keytruda (pembrolizumab) as a first-line treatment for recurrent head and neck cancer.
Beginning Jan. 1, 2026, China will apply provisional import tariff rates lower than the most-favored-nation rates on 935 items, the State Council announced. The move aims to boost collaboration between domestic and international sectors, and to leverage resources of both to expand the supply of high-quality goods.
It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.
China’s National Medical Products Administration (NMPA) has issued guidance governing online sales of medical devices with a focus on inspections of the products’ manufacturing facilities. The agency made it clear that the manufacturer will have to deal promptly with any deviations from the regulations or face enforcement action, signaling a new era of tighter scrutiny of online sales of these products.
Advanced Biomed Inc. reported Dec. 30 the sale of its wholly owned Hong Kong subsidiary, Advanced Biomed (HK) Ltd., and related intellectual property to buyer Wei Ha Hui for $23,000.
Bayosthiti AI Pvt Ltd. aims to make RNA sequencing and AI-based preventive health care affordable and accessible for the Indian market, leveraging intellectual property from its parent company, Biostate AI Inc.
Intuitive Surgical Inc. strengthened its position as the market leader in robotic-assisted surgery in 2025 on the back of increasing demand for minimally invasive procedures. Intuitive’s da Vinci system is seeing robust growth in procedures and installations, fueling increased revenues.
Livsmed Inc. closed the year’s biggest Kosdaq IPO with a ₩135.85 billion (US$94 million) haul Dec. 24. Livsmed specializes in the development of hand-held multi-joint laparoscopic surgical instruments for minimally invasive procedures.