2025-09-28
FDA AI guidance is forcing more transparency in AI-driven devices. Surgical robotics is diversifying: modular, mobile, and local systems on the rise. Wearables are now mainstream clinical tools, not just consumer gadgets. Europe’s MDR/IVDR rules are slowing down certification, sparking calls for reform. The future belongs to integrated solutions: device + software + data + service.
2025-09-26
The Trump administration initiated a national security investigation under Section 232 of the Trade Expansion Act on September 2, 2025, targeting imported medical devices such as masks, syringes, and infusion pumps. Potential high tariffs have caused stocks of companies like GE HealthCare and Becton Dickinson to fall. If implemented, tariffs could reshape the global medical supply chain, posing challenges for Chinese exports while U.S. companies grapple with rising costs and production relocation pressures.
Daxor's Next-Gen BVA Analyzer Ushers New Era in Heart Failure Management with FDA Clearance
2025-09-25
Daxor Corporation has received FDA clearance for its next-generation Blood Volume Analyzer (BVA), a groundbreaking medical device that revolutionizes fluid management for heart failure patients. The new analyzer is three times faster than its predecessor, requires 50% less blood draw, and maintains over 95% accuracy. This portable, battery-operated system will be unveiled at the Heart Failure Society of America's Annual Scientific Meeting, where new clinical data will demonstrate its potential to set a new standard in personalized heart failure care. The technology addresses a critical gap in current medical practice by providing precise, real-time blood volume measurements to guide treatment decisions, potentially reducing complications and improving patient outcomes.
2025-09-24
Microbot Medical Inc. has received FDA 510(k) clearance for its LIBERTY® Endovascular Robotic System, a pioneering single-use robotic device designed for peripheral vascular procedures. This system allows surgeons to operate remotely from a console, enhancing precision while reducing exposure to radiation. As the first single-use robot of its kind, it aims to lower hospital costs by eliminating reprocessing needs and minimizing infection risks. The company is now planning its U.S. commercial launch, positioning the LIBERTY® system to transform standard practices in endovascular care.
Medtronic Moves Forward with Planned Spin-off of Diabetes Business 'MiniMed'
2025-09-23
Medtronic is proceeding with the separation of its diabetes care unit into an independent company called MiniMed, citing operational differences and a need for focused innovation.
Scientific Health丨AI Empowerment! 2025 CIFTIS Digital Medical Care Has Warmth
2025-09-23
At CIFTIS, AI and smart devices, such as portable fundus cameras and companion robots, were highlighted for improving children's healthcare accessibility, particularly in eye health and autism screening.
ADD：Touqiao Industrial Park, Guangling District, Yangzhou City, Jiangsu Province
E-mail: 397125492@qq.com
TEL：0086-514-87266777
