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.
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.
Dental
AI/ML engineering and FDA clearance of a radiology AI/ML quantitative imaging SaMD.
Radiology
Rapid response to hold letter with major cybersecurity findings. Clearance 3 months later.
Radiology
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