We help companies commercialize and FDA-clear medical device software and AI. Whether you're looking for regulatory consulting, a software partner, cybersecurity support, or a full-service partner—we can help.
Don't take our word for it.
Founder and Managing Director
Managing Partner
CEO MedWeb
Co-Founder and Chairman of Retrieve Medical
CEO of Dionysus Digital Health
CEO at SimBioSys
CEO of Radical Imaging
Co-Founder at AI Metrics & Chair of Diagnostic Imaging at St. Jude Children's Research Hospital
We've helped develop software and achieve FDA clearance on more than 70 projects since we were founded in 2012
OrthoVentions, a medical device startup accelerator partnering with Hospital for Special Surgery, needed FDA regulatory strategy for Gemini—an AI-powered SaMD platform creating 3D joint models from 2D MRI. After finding two other consultants suboptimal, they chose Innolitics for proactive FDA expertise, pragmatic approach that preserved strong existing work, and strategic project management. Innolitics delivered a robust FDA Pre-Submission on time and within budget. The outcome: "They did what they said they were going to do, and they did it within the budget that they said they were going to do. So there were no surprises."
Dr. Jagi Gill, MD - Radiology
Innolitics partnered with Cube Click to develop Smile Dx, an AI-powered dental diagnostic tool that enhances dentists' ability to detect caries (cavities), periodontal disease (gum disease), and periapical radiolucencies (PARL). The project showcases our engineering expertise through the development of a comprehensive web application with deep learning capabilities, while also demonstrating our regulatory competence by successfully guiding the product through FDA pre-submission and 510(k) submission processes.
Dr. Richard Ricci, DDS, MS, FAGD, Dr. Andrea R. Cambria, DDS, FAGD - Dental
We implemented a data-intensive DICOM image processing system to aid clinical workflows. We built this as a modern web application for ease of use. We prepared a complete 510(k) submission for the device and obtained FDA clearance. Both engineering and FDA clearance were completed within 14 months, starting from the ground up.
Tim Szczykutowicz, PhD - Radiology
Innolitics partnered with NeuroSpectrum Insights to develop Gyricalc, a diagnostic tool for neurodevelopmental conditions in children as young as two years old. This project showcases our engineering expertise in transforming a research idea into a fully developed web application and highlights our regulatory proficiency in successfully navigating the FDA pre-submission and 510(k) submission processes.
Andrew Stewart - Neurology
AI/ML engineering and FDA clearance of a radiology AI/ML quantitative imaging SaMD.
Dr. Steven Rothenberg MD - Radiology
Time critical responses to FDA’s concerns with clearance soon after
Tushar Pandey - Radiology
Guide an engineering team without FDA experience through a 510(k) for a breakthrough in vitro diagnostic (IVD) platform
VP of Systems R&D - Microbiology
Rapid response to hold letter with major cybersecurity findings. Clearance 3 months later.
Andrei Migatchev - Radiology
Fast 510(k) for a medical image viewer starting with no documentation
Rob Lewis - Radiology
Guide an engineering team without FDA experience through a 510(k) for a medical image viewer
Amr Abodraiaa, Momen Mohamed - Radiology
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