As AI Surgery rapidly enters operating rooms and diagnostic systems worldwide, Baird Medical this week launched regulatory registration for its AI-powered surgical platform across the US, Europe, and China, even as growing lawsuits and FDA reports raise alarms over the safety of AI-driven medical devices.
The announcement highlights the accelerating race to transform healthcare through automation and intelligent surgical systems. Baird Medical said its newly developed software uses a proprietary AI model to automate clinical tasks including anatomical mapping, treatment planning, and surgical simulations.
The platform is designed to integrate with the company’s future robotic surgical systems, creating what it described as a “closed-loop surgical ecosystem” spanning diagnosis, surgery, and post-operative evaluation.
The company, already known for its minimally invasive microwave ablation technology, said the system aims to improve precision and patient outcomes while expanding demand for AI Surgery interventions globally.
The Baird Medical devices are already used in more than 30 hospitals and clinics across the US, including the Mayo Clinic and Columbia University Medical Center, while the company also holds a leading position in China’s thyroid microwave ablation market.
AI Enters the Operating Room
Baird Medical’s expansion comes at a time when AI-powered healthcare tools are rapidly reshaping modern medicine. According to FDA data, more than 1,357 AI-enhanced medical devices have now been authorized in the US, more than double the total approved by the end of 2022.
Many of these systems rely on machine learning and deep learning to support diagnostics, imaging, and surgical navigation. Hospitals and physicians increasingly use AI Surgery tools to streamline workflows, reduce manual tasks, and improve surgical accuracy.
Generative AI chatbots are also becoming common in clinics, helping doctors summarize notes and assist with administrative work.
But as adoption accelerates, regulators and researchers are struggling to keep pace with safety oversight. A study conducted by researchers from Johns Hopkins University, Georgetown University, and Yale University found that 60 FDA-authorized AI medical devices were linked to 182 recalls, with nearly half occurring within a year of approval.
Five current and former FDA scientists told Reuters the agency has also faced staffing shortages and increasing workloads while reviewing a growing number of AI Surgery technologies. Experts warned that traditional approval systems may not fully address the unpredictable behavior of adaptive AI technologies.
Lawsuits And Safety Fears Intensify
The concerns became more visible following lawsuits tied to the AI-assisted TruDi Navigation System originally developed by Acclarent, a former subsidiary of Johnson & Johnson that was later acquired by Integra LifeSciences.
The AI device, used during sinus surgeries, allegedly provided incorrect guidance during procedures, contributing to severe injuries including skull punctures, cerebrospinal fluid leaks, and strokes. FDA adverse event reports linked the system to at least 100 malfunctions and injuries by late 2025.
One patient, Erin Ralph, alleged in a lawsuit that the system misdirected her surgeon during a 2022 procedure, damaging her carotid artery and triggering a stroke that required part of her skull to be removed to relieve brain swelling.
Another patient, Donna Fernihough, filed a lawsuit after suffering a stroke during a sinuplasty operation in 2023.
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