BOSTON– Basil Systems, a leading AI-powered product lifecycle intelligence platform for the life sciences industry, has launched its new MedTech Safety Signaling solution, a first-of-its-kind technology designed to transform post-market surveillance into a proactive risk detection and prevention system.
Medical device manufacturers operate in one of the most complex and high-stakes areas of healthcare, monitoring millions of disconnected data points each year — from adverse event reports and recalls to regulatory filings and internal quality data. Traditionally, safety and product quality teams have had to manually process this information, often detecting issues only after patient harm or costly recalls occur.
Basil’s Safety Signaling module addresses this challenge by leveraging a proprietary platform that integrates the world’s most comprehensive indexed dataset of regulatory filings, clinical trials, adverse event reports, recalls, and guidances. The platform enables large language models to identify subtle, predictive correlations that would otherwise go unnoticed.
The system begins with a post-market event — such as a recall, warning letter, or inspection finding — and queries millions of narratives, inspection reports, and citations for contextual similarities to the root cause. Rather than relying on simple keyword searches, Safety Signaling interprets meaning and clusters events using confidence scores, root-cause insights, and traceable links to original reports.
By uncovering patterns related to device design flaws, manufacturing defects, or usage environments, Basil’s Safety Signaling provides safety, quality, and regulatory teams with actionable intelligence. Insights can be seamlessly exported into quality management systems or business intelligence tools for immediate operational use.
The technology is already being deployed by several of the world’s largest medical device manufacturers — including Johnson & Johnson, Medtronic, and Boston Scientific — to identify recall risks earlier, accelerate corrective and preventive action (CAPA) strategies, benchmark safety profiles, and inform R&D teams for improved product design.
“Medical device companies are drowning in post-market data but starving for predictive analytics and intelligence,” said Anthony Cirurgiao, CEO and founder of Basil Systems. “Our AI-powered Safety Signaling delivers those insights. We directly address the challenges of early risk detection and root cause analysis by using verifiable data to ignite actionable insights. This isn’t about finding more data; it’s about finding the critical connections in the data that already exist. We help our customers predict and prevent issues, improve product design, and solidify market leadership, while championing patient safety.”
With the launch of Safety Signaling, Basil Systems is setting a new standard for post-market intelligence in the medical device industry. By combining the industry’s most complete dataset with a purpose-built AI enrichment platform, the system provides manufacturers with defensible, verifiable insights that enhance compliance, protect patient safety, and preserve brand trust. The solution avoids the inaccuracies common to generic AI tools, grounding all outputs in traceable source data while remaining intuitive and scalable for enterprise-wide deployment.
