We help companies commercialize and FDA-clear medical device AI. Whether you're looking for regulatory consulting, a software partner to integrate and secure your software, or a full-service partner—we can help.
You need a software-development partner for a new or existing medical-device product.
You need to determine the best path to the US market or have other custom regulatory needs.
Don't take our word for it.
Managing Partner
CEO of Dionysus Digital Health
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
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
AI/ML engineering and FDA clearance of a radiology AI/ML quantitative imaging SaMD.
Dr. Steven Rothenberg MD - Radiology
Rapid response to hold letter with major cybersecurity findings. Clearance 3 months later.
Andrei Migatchev - 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.