The context-aware, multi-lingual AI agents act like a 24/7 digital FDA reviewer, helping MedTech companies improve first-time 510(k) submission success rates.
PALO ALTO, CA, UNITED STATES, February 11, 2026 /EINPresswire.com/ — February 11, 2026, (Palo Alto, California) – Getting a medical device through the FDA is a major bottleneck. Companies spend months preparing all-important 510(k) submissions, yet an FDA report shows that 76 percent fail on the first try.
The problem isn’t missing paperwork. It’s inconsistent information.
i-GENTIC AI’s new suite of MedTech agents closes this gap. Powered by its GENIE™ reasoning engine, the context-aware, multi-lingual AI agents act like a 24/7 digital FDA reviewer. Internal data shows first-time submission success rates improve by up to 97 percent, while approval timelines drop by an average of six weeks.
“FDA reviewers look for a consistent narrative,” says 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.”
To pass 510(k), mountains of pages covering intended use, risk controls, testing, and labeling must align. If they don’t, the FDA hits “pause,” requesting more information or rejecting the file. These mistakes add months of delays and tens of thousands in extra costs for medical device manufacturers.
“Our agents are built to surface where that narrative fractures. 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 MedTechs need before they submit,” adds Timsah, who has previously held executive roles at IQVIA, MassMutual, and GSK.
Former Medtronic CTO Dr. Ken Washington is now Chairman of the Board at i-GENTIC. He has overseen regulatory and technology strategy across some of the most complex medical device portfolios in the world.
“Traditional systems act like a basic checklist, telling you that a document exists. But it can’t tell you if your data still makes sense after months of design changes and internal reviews,” Washington explains.
“As device portfolios scale, complexity grows faster than teams can manually track across systems. Context-aware agents help surface weak links early, when teams still have time to fix them thoughtfully rather than discovering them months later through regulatory back-and-forth.”
Scott Van Valkenburgh, board member at i-GENTIC and SVP at low-code automation platform Appian, says AI-driven compliance changes the ROI of the 510(k) submission process.
“Speed to clearance is a major competitive advantage. Traditional AI tools are no longer enough for the rigors of FDA scrutiny,” he explains. “Regulations are in place to make sure devices are safe, and context-aware agents can help MedTechs cross the 510(k) finish line ahead of their competitors.”
Finding the break before review: a regulatory case study
In one recent engagement, a MedTech firm’s 510(k) documentation passed all internal checks, yet i-GENTIC’s AI agents detected a critical flaw: a late-stage change to the intended use no longer aligned with the risk analysis and test results.
No individual document was incorrect, but the collective data told an inconsistent story. The MedTech agents traced this logic break across the Design History File and flagged it instantly. By fixing the alignment before filing, the team avoided an almost-guaranteed FDA rejection.
Beyond 510(k)
While the 510(k) process is a common bottleneck, i-GENTIC’s platform is designed for broader use across highly regulated industries. The same agentic approach is used to help compliance and governance teams navigate complex regulations, SOPs, and frameworks where consistency and traceability matter.
i-GENTIC is part 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, replacing fragmented tools with continuous, context-aware regulatory intelligence.
For more information, visit https://igenticai.com
Zahra Timsah
i-GENTIC AI
zahratimsah@igenticai.com
Legal Disclaimer:
EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
