Nia Therapeutics Inc. reported data from an in vivo study of its Smart Neurostimulation System, an AI-based brain-computer interface (BCI), which demonstrated its ability to perform chronic sensing, neural-state decoding and programmable stimulation.

In 2025, the momentum behind robotic-assisted surgical systems continued to accelerate on the back of increasing demand for minimally invasive procedures. In many parts of the world, these technologies are reshaping surgical procedures by improving precision and efficiency through high resolution imaging, AI and refined instrument control. This is resulting in fewer complications, faster recovery and improved patient outcomes.

IPOs top the list of the big stories in 2025 in med tech. Thirty med-tech companies went public, raising nearly $12 billion, two orders of magnitude more than in 2023 and almost 20 times more than raised in 2024.

The U.S. FDA recently cleared Medtronic plc’s Hugo robotic-assisted surgery system and CMR Surgical Ltd.’s Versius Plus system, adding new options to the U.S. market to meet rising demand for robotic procedures. While Intuitive Surgical Inc. currently dominates the soft tissue surgical robotics space, these new entrants will provide hospitals and health care systems with greater choices when it comes to purchasing systems and expanding systems.

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.

The U.S. Centers for Medicare & Medicaid Services announced that several Medicare administrative contractors have formally withdrawn local coverage determinations for skin substitutes. There are questions, however, as to whether this will bring an end to excess spending on these products even though the agency has capped the rate paid for entire classes of products.