Lexim Sphere › Engines
Purpose-Built Engines
One Mission.
Lexim Engines are purpose-built AI agents that monitor, map, analyze, translate, and remediate — each designed for a specific and demanding compliance challenge. Running continuously across your regulatory landscape so your team can focus on decisions, not data collection.
4
STRATEGIC ENGINES
3
EXECUTION
ENGINES
7
SYNTHESIS
ENGINES
2+
COMING
SOON
Strategic Engines
Intelligence that
never sleeps.
Four Engines running continuously in the background — monitoring, alerting, tracking, and mapping the global regulatory landscape so your team is never caught off guard.
Live Monitoring
Periscope
Your Competitive Radar. Always On.
Select the companies and FDA product codes you want to watch — Periscope does the rest. The moment anything happens to a watched entity across any monitored source, you receive an alert via email, dashboard notification, and your Sphere feed simultaneously.
Precision Tracking
Vigil
Every Update. In Order. In Context.
Tag any regulation — global or US — and Vigil follows it for its entire lifecycle. When anything changes, you're alerted immediately. Every related document is presented in chronological order, from original guidance to the latest amendment, building a living regulatory dossier.
FDA Pulse
FDA Monitoring. Continuous. Comprehensive.
The highest-volume regulatory monitoring Engine in the suite — dedicated to the FDA, the world's most active and consequential regulatory body. Pulse continuously watches every FDA output channel and delivers immediate alerts the moment guidance, rules, notices, or enforcement actions are published.
Global pulse
Global Regulatory Intelligence. Daily.
Your daily intelligence briefing across the other 14 regulatory regimes in Lexim Sphere — EU MDR, PMDA, Health Canada, TGA, and more. Global Pulse sweeps global regulatory activity and delivers a structured daily update covering publications, guidance changes, and enforcement actions across every monitored market.
How They Work Together
FDA Pulse and Global pulse operate on the same underlying monitoring infrastructure — purpose-built for continuous regulatory surveillance. FDA Pulse handles the FDA's volume and velocity as a dedicated feed; Global Pulse covers the global landscape with a daily cadence that matches the lower but equally critical output of international regulators. Together they ensure no regulatory development — anywhere in your markets — goes unnoticed.
Execution Engines
From intelligence
to action.
Strategic Engines tell you what is happening. Execution Engines help you respond — analyzing gaps, comparing documents, translating materials, and remediating your internal documentation against the world's regulatory requirements.
Gap Analysis
Bridge
Find Every Gap. Plan Every Fix.
Load an internal document — an SOP, work instruction, or policy — and run it against any regulation, guidance, or commercial standard. Bridge produces a sophisticated, structured gap report that opens with a full analysis plan, then delivers every identified gap with specific remediation guidance.
Document Comparison
Clarity
Two Documents. Every Difference. Instantly.
Take any two versions of any document and Clarity surfaces every difference, inconsistency, and alignment gap between them. Whether you're comparing old and new regulations, cross-jurisdictional guidance, or SOPs from two different divisions — Clarity brings the differences into sharp focus.
Relay
50+ Languages. ISO-Standard Precision.
Technical and regulatory translation is one of the most costly and time-consuming challenges in global Life Sciences. Relay applies ISO translation standards specifically to regulatory and technical materials — delivering accurate, compliant translations in and out of 50+ languages at a fraction of traditional cost and turnaround time.
Predicate Finder
Your Strongest 510(k) Predicate. Found.
Searching the full 510(k) and De Novo database manually for predicate candidates is one of the most labor-intensive steps in the clearance process. Predicate Finder automates the search — analyzing device descriptions, indications for use, technology characteristics, and clearance history to surface your strongest predicate chain.
Classification
Your Device Class. Your Pathway. Confirmed.
Determining the correct FDA device classification, product code, and regulatory pathway early in development is critical — and getting it wrong is costly. The Classification Engine analyzes the full FDA classification database and historical precedent to confirm your device's classification and map the most appropriate regulatory pathway.
Synthesis Engines
On-demand AI analysis.
Any document. Any layer.
The same six-layer intelligence framework that powers Lexim Synthesis is available as individual on-demand Engines — apply any single Synthesis analysis to any document you provide, at low cost, instantly.
Concise Summary
Executive-level digest of any document — the essential points in the shortest possible form, ready for leadership briefings.
Detailed Summary
Full structured breakdown for practitioners — comprehensive, organized, and navigable without reading the source document.
Impact Analysis
Cross-functional business impact mapped by organizational function — R&D, Quality, Regulatory Affairs, Manufacturing, Commercial.
Action Items
Specific required steps extracted from the document, structured by responsible function, and prioritized by urgency.
FAQs
Plain-language answers to anticipated questions — ready to share with cross-functional stakeholders who need clarity without the source document.
Supporting Links
Related documents, referenced standards, and connected regulatory materials surfaced — each with their own AI analyses already applied.
Discussion Framework
Built-in structure for your team's assessment process — so the conversation about what a document means for your organization starts immediately, with an auditable record of every decision made.