New multilingual AI agents are designed to help MedTech teams identify narrative and traceability breaks across intended use, risk controls, testing, and labeling before filing

PALO ALTO, Calif., Feb. 11, 2026 i-GENTIC AI today announced a new suite of context-aware, multilingual MedTech agents designed to help medical device manufacturers improve the quality and consistency of FDA 510(k) submissions. Preparing a 510(k) often takes months, yet many submissions require additional information requests or are rejected due to inconsistencies across documents, evidence, and claims, creating delays and added costs for manufacturers.

The company’s platform, powered by its GENIE™ reasoning engine, is designed to function as a continuous pre-submission review layer that surfaces mismatches across the submission narrative, including drift between intended use, design assumptions, performance testing, risk controls, and labeling. According to i-GENTIC AI internal engagement data, customers have improved first-time submission success rates by up to 97 percent and reduced approval timelines by an average of six weeks.

“FDA reviewers look for a consistent narrative,” said Zahra Timsah, founder and CEO of i-GENTIC AI. “They need to see that evidence, logic, and traceability for your device remain solid across the entire submission.”

The core submission problem: inconsistency, not missing documents

A 510(k) submission typically includes extensive documentation across intended use, risk management, verification and validation, performance testing, and labeling. Even when every individual document is complete, inconsistencies between documents can create a fragmented story. When the evidence and claims stop aligning, reviewers may issue requests for additional information or halt review until issues are resolved, extending timelines and increasing costs.

“Our agents are built to surface where that narrative fractures,” Timsah said. “They identify when an intended use statement drifts from the design assumptions it was based on, when performance testing no longer supports the claim being made, or when a documented risk control no longer mitigates the real-world behavior of the device. That is the level of scrutiny teams face during FDA reviews, and that is the level of scrutiny MedTech teams need before they submit.”

Timsah has previously held executive roles at IQVIA, MassMutual, and GSK.

Industry leadership perspective on scale and complexity

Former Medtronic CTO Dr. Ken Washington, now Chairman of the Board at i-GENTIC AI, has overseen regulatory and technology strategy across large-scale medical device portfolios.

“Traditional systems act like a basic checklist, telling you that a document exists,” Washington said. “But they cannot tell you whether the data still makes sense after months of design changes and internal reviews.”

“As device portfolios scale, complexity grows faster than teams can manually track across systems. Context-aware agents can help surface weak links early, when teams still have time to fix them thoughtfully rather than discovering them later through regulatory back-and-forth.”

Scott Van Valkenburgh, board member at i-GENTIC AI and SVP at low-code automation platform Appian, added that AI-driven compliance changes the economics of the 510(k) process.

“Speed to clearance is a major competitive advantage,” Van Valkenburgh said. “General-purpose AI tools are rarely designed for the rigor of FDA scrutiny. Regulations exist to protect patients, and context-aware agents can help MedTech teams reach clearance faster while maintaining the discipline that review demands.”

Finding the break before review: a regulatory case study

In a recent engagement, a MedTech firm’s 510(k) documentation passed internal checks, yet i-GENTIC AI’s agents flagged a critical issue: a late-stage change to the intended use no longer aligned with the risk analysis and test results.

No individual document was incorrect. The collective set of documents, however, told an inconsistent story. The agents traced the logic break across the Design History File and flagged the misalignment. By correcting the issue prior to filing, the team avoided a likely FDA request for additional information or rejection driven by cross-document inconsistency.

Beyond 510(k)

While the 510(k) pathway is a common bottleneck, i-GENTIC AI’s platform is designed for broader use across regulated industries where traceability, internal consistency, and evidence-backed decisioning matter. The same approach can be applied to complex regulations, SOPs, and governance frameworks where teams must maintain alignment across documents, systems, and workflows.

i-GENTIC AI is a member of AdvaMed, the MedTech association that advocates for ethical business practices.

About i-GENTIC AI

i-GENTIC AI builds agentic AI systems for regulated industries, starting with MedTech. Its GENIE™ platform delivers a unified reasoning engine that orchestrates specialized AI agents across workflows, documents, and systems, providing continuous, context-aware regulatory intelligence to support submission readiness and compliance operations.

For more information, visit igenticai.com.

Media Contact

Zahra Timsah
Founder and CEO, i-GENTIC AI
[email protected] 

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