The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the rub for some stakeholders. The Advanced Medical Technology Association pressed the agency to ensure that the final guidance takes into account the hazards of electronic access during remote BiMo audits, but the final guidance makes no such concessions.

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.

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.

Every year seems to introduce novel approaches to litigation when it comes to product liability and other theories of harm from medical devices, and 2025 was no exception. One of the more interesting cases was CLF 007 v. Cooper Surgical, which broke new ground for its handling of non-existent state legal precedent.

The new U.S. FDA leadership has broken with standing agency practice in several areas and in the latest move seeks to cut out the middleman in FDA contracting practices, a development that might aid small firms that are financed by venture capital.