We are an engineering, regulatory, and management consulting firm focused exclusively on AI-enabled medical device software. We help CEOs and founders turn breakthrough clinical AI into FDA-cleared, market-ready products—with guaranteed timelines and outcomes—All under one roof.
Recent case study
Multi-Year Partnership: CBCT Development → FDA Clearance → Maintenance → Support → M&A Support
The client’s engineers had never touched regulatory. We got them FDA cleared on their first submission. Now they are self sufficient.
Client's first medical device. No documentation. 510(k) cleared in 12 months while engineers stayed focused on dev.
Client received hold letter with major cybersecurity findings. Engaged Innolitics. Cleared in 3 months.
Resolved FDA hold letter that would have required repeating the entire clinical study. Cleared shortly after.
Built and cleared an AI cardiomegaly detector end-to-end: algorithm R&D to 510(k) clearance in under 12 months.
Full-cycle development of GyriCalc, a first-of-its-kind pediatric neuroimaging diagnostic. FDA cleared (K250686) July 2025. Filed for IPO in June 2025.
Built and cleared a DICOM image processing SaMD in 14 months. Full-cycle: engineering to 510(k) clearance.
We built the app, trained the AI, ran the MRMC study, and cleared FDA.
FDA regulatory strategy and Pre-Submission for an AI platform converting 2D MRI to 3D joint models. Delivered on time and budget
Completed DHF and 510(k) documentation in 7 weeks. FDA cleared 4 months after submission."
We isolated Neosoma's new CNN for FDA review, won clearance in 3 months, and built a framework for every product after.
We secured breakthrough status and drove a 3-month FDA submission for an AI breast-risk SaMD.
Trusted by
Our FDA Clearances
Board meeting next month?
Four weeks to a plan and budget. Twelve months to a 510(k) letter on FDA letterhead. The same team that builds the device commits to the date.
For AI SaMD founders deciding how much to raise and how long the first FDA 510(k) will take. A 37-company benchmark: $16.0M market-comparable media...
Yujan Shrestha
For founders, CEOs, and CFOs at AI/ML medical device companies trying to decide how much to spend on a 510(k). A meta-analysis of 35 post-IPO AI/ML...
Yujan Shrestha
A Pre-Sub is a mechanism for requesting formal written feedback from the FDA, and (optionally) a one-hour meeting. Pre-subs are a useful means to m...
J. David Giese
Most first-time teams burn over a year overbuilding documentation FDA never asks for. Here is a section-by-section breakdown of a cleared AI/ML SaM...
Yujan Shrestha
A “quick” reference guide grouping the example 510(k) clearances by their product code/regulation, summarizing required testing and the rationale b...
Meri Martinez
This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. It also includes exa...
J. David Giese &
Every great partnership starts with a conversation. Fill out the form below for a discovery call, and an Innolitics team member will contact you soon.
I learned more from an hour-long Innolitics sales call than an entire paid engagement from other consultants.
Richard Clark
Executive in Residence at Washington University