Stereotaxis Inc. secured U.S. FDA approval for its Magic magnetic interventional ablation catheter, marking a key step in the company’s effort to evolve from a niche robotics supplier into a more vertically integrated electrophysiology technology provider. The approval positions Magic as Stereotaxis’ first proprietary robotic ablation catheter in the U.S. and follows a series of regulatory and commercial milestones in recent months that reset the company’s growth narrative.

Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.

Software as a service has typically been less susceptible to liability than products, but that may soon come to an end if the AI LEAD Act, sponsored by a bipartisan pair of members of the Senate, gains sufficient traction.

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.

The U.K. National Institute for Health and Care Excellence posted a draft update on its recommendations for ovarian cancer testing, proposing several changes that may lead to earlier intervention in the ovarian cancer disease cycle.

Australia’s Therapeutic Goods Administration posted a proposed rework of the agency’s conformity assessment procedures that would align with EU regulations, but the agency stated clearly that it is aware of some of the hazards of further alignment with the troubled European regulations.

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.

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.

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.