We've helped develop software and achieve FDA clearance on more than 70 projects since we were founded in 2012
FDA regulatory strategy and Pre-Submission for an AI platform converting 2D MRI to 3D joint models. Delivered on time and budget
Dr. Jagi Gill, MD - Radiology
We built the app, trained the AI, ran the MRMC study, and cleared FDA.
Dr. Richard Ricci, DDS, MS, FAGD, Dr. Andrea R. Cambria, DDS, FAGD - Dental
Built and cleared a DICOM image processing SaMD in 14 months. Full-cycle: engineering to 510(k) clearance.
Tim Szczykutowicz, PhD - Radiology
Full-cycle development of GyriCalc, a first-of-its-kind pediatric neuroimaging diagnostic. FDA cleared (K250686) July 2025. Filed for IPO in June 2025.
Andrew Stewart - Neurology
Built and cleared an AI cardiomegaly detector end-to-end: algorithm R&D to 510(k) clearance in under 12 months.
Dr. Steven Rothenberg MD - Radiology
Resolved FDA hold letter that would have required repeating the entire clinical study. Cleared shortly after.
Tushar Pandey - Radiology
Other consultants couldn't make progress. We finished their software docs in 4 months — 3x faster than expected.
VP of Systems R&D - Microbiology
Client received hold letter with major cybersecurity findings. Engaged Innolitics. Cleared in 3 months.
Andrei Migatchev - Radiology
Client's first medical device. No documentation. 510(k) cleared in 12 months while engineers stayed focused on dev.
Rob Lewis - Radiology
The client’s engineers had never touched regulatory. We got them FDA cleared on their first submission. Now they are self sufficient.
Amr Abodraiaa, Momen Mohamed - Radiology
Multi-Year Partnership: CBCT Development → FDA Clearance → Maintenance → Support → M&A Support
Nathan Childress, PhD, DABR, Christof Baltes, PhD - Radiation Oncology
Cardiology
Reframed regulatory strategy after FDA pushback. BDD granted in \~3 months.
Read the case study →Digital Health
Delivered a working AI prototype that automates Medicare coding analysis in under 4 weeks.
Read the case study →Pre-Clinical
Over 10x improvement to in-house image-processing GUIs using AI and other optimizations
Read the case study →Ophthalmology
**We aligned their FDA strategy to their funding rounds. Phased approach. Lower risk. Faster to market.**
Read the case study →Radiology
Existing EU data. Strategy designed to get to U.S. market with minimal extra effort.
Read the case study →Digital Health
Accelerated software design and development for intake software platform
Read the case study →Radiology
Indistinguishable from Full-Time Staff. Software development and devops support for large existing engineering team
Read the case study →Tooling
Custom software development with PACS performance requirements
Read the case study →Radiology
Prototype → 510(k) → QMS → FDA audit passed. Multi-year partnership with ongoing development.
Read the case study →Neurology
MATLAB to Python port with performance improvements, documentation, and verification
Read the case study →Tooling
Online tool for patients to browse MR, CT, X-Ray, and Ultrasound images in a browser
Read the case study →Tooling
Online tool for subscribing to new alerts in the official FDA database
Read the case study →Tooling
Browse the FDA product code, 510(k), and PMA databases online
Read the case study →Radiation Oncology
We built the image processing, trained the neural network, and delivered a cloud app. Fully automated.
Read the case study →Pre-Clinical
Staff augmentation for highly-technical, PhD heavy engineering team
Read the case study →Tooling
High-speed python/C++ module for a superior interpolation algorithm
Read the case study →Tooling
Popular free tool for browsing the main medical imaging standard
Read the case study →Tooling
Python module for extracting data contained in DICOM files
Read the case study →Ear Nose and Throat
UI design, Custom C++, Qt, Python development, IEC 62304 and FDA software documentation for a successful 510(k) submission
Read the case study →Radiation Oncology
\"uilt the dashboard, integrated with Mosaiq EMR. Still running 8 years later.
Read the case study →Gastroenterology and Urology
UI and algorithm design and development for Android and web
Read the case study →Pre-Clinical
Accelerated software development compared to prior general-purpose software team
Read the case study →Tooling
Medical Image Viewer JavaScript and React toolkit
Read the case study →Tooling
Testing methodology and an associated Python framework for regression testing algorithms and AI/ML models
Read the case study →
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