We've helped develop software and achieve FDA clearance on more than 70 projects since we were founded in 2012
We secured breakthrough status and drove a 3-month FDA submission for an AI breast-risk SaMD.
We isolated Neosoma's new CNN for FDA review, won clearance in 3 months, and built a framework for every product after.
Completed DHF and 510(k) documentation in 7 weeks. FDA cleared 4 months after submission.”
FDA regulatory strategy and Pre-Submission for an AI platform converting 2D MRI to 3D joint models. Delivered on time and budget
We built the app, trained the AI, ran the MRMC study, and cleared FDA.
Built and cleared a DICOM image processing SaMD in 14 months. Full-cycle: engineering to 510(k) clearance.
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 an AI cardiomegaly detector end-to-end: algorithm R&D to 510(k) clearance in under 12 months.
Resolved FDA hold letter that would have required repeating the entire clinical study. Cleared shortly after.
Other consultants couldn't make progress. We finished their software docs in 4 months — 3x faster than expected.
Client received hold letter with major cybersecurity findings. Engaged Innolitics. Cleared in 3 months.
Client's first medical device. No documentation. 510(k) cleared in 12 months while engineers stayed focused on dev.
The client’s engineers had never touched regulatory. We got them FDA cleared on their first submission. Now they are self sufficient.
Multi-Year Partnership: CBCT Development → FDA Clearance → Maintenance → Support → M&A Support
Cardiology
Reframed regulatory strategy after FDA pushback. BDD granted in ~3 months.
Digital Health
Delivered a working AI prototype that automates Medicare coding analysis in under 4 weeks.
Pre-Clinical
Over 10x improvement to in-house image-processing GUIs using AI and other optimizations
Ophthalmology
**We aligned their FDA strategy to their funding rounds. Phased approach. Lower risk. Faster to market.**
Radiology
Existing EU data. Strategy designed to get to U.S. market with minimal extra effort.
Digital Health
Accelerated software design and development for intake software platform
Radiology
Indistinguishable from Full-Time Staff. Software development and devops support for large existing engineering team
Radiology
Gap analysis for an SaMD company that got audited that same year and passed with minimal findings
Radiology
Prototype → 510(k) → QMS → FDA audit passed. Multi-year partnership with ongoing development.
Neurology
MATLAB to Python port with performance improvements, documentation, and verification
Radiation Oncology
We built the image processing, trained the neural network, and delivered a cloud app. Fully automated.
Pre-Clinical
Staff augmentation for highly-technical, PhD heavy engineering team
Ear Nose and Throat
UI design, Custom C++, Qt, Python development, IEC 62304 and FDA software documentation for a successful 510(k) submission
Radiation Oncology
Built the dashboard, integrated with Mosaiq EMR. Still running 8 years later.
Gastroenterology and Urology
UI and algorithm design and development for Android and web
Pre-Clinical
Accelerated software development compared to prior general-purpose software team
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Our Medtech tips will help you get safe and effective Medtech software on the market faster. We cover regulatory process, AI/ML, software, cybersecurity, interoperability and more.
