Medical Device Software and AI Experts

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.

Our Services

Our Solutions

Why Innolitics?

  • All we do is medical-device software
  • Developed software for over 70 medical devices since 2012
  • Team has FDA cleared more than 50 SaMD and SiMD products
  • Four AI/ML and image-processing experts on our team, including two PhDs
  • Cybersecurity expertise in threat modeling, security risk management, SBOMs and more

Trusted by emerging startups to category-leading healthcare companies.

Don't take our word for it.

Companies like yours create medical device software with Innolitics

We've helped develop software and achieve FDA clearance on more than 70 projects since we were founded in 2012

Smile Dx (Dental CADe AI/ML SaMD)

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.

Read the case study

Dental

Guided 510(k)Software DevelopmentWeb-AppAI/MLImage Processing510k
Logo, Cube Click, Inc.

Body Check (FDA Cleared End to End AI/ML SaMD)

AI/ML engineering and FDA clearance of a radiology AI/ML quantitative imaging SaMD.

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Radiology

Medical Imaging AI DevelopmentSoftware DevelopmentRegulatory StrategyFDA Hold Letter ResponseFast 510(k)FDA CybersecurityAI/ML510kImage Processing
Logo, Body Check

Radify Triage Cybersecurity FDA AI Request Response

Rapid response to hold letter with major cybersecurity findings. Clearance 3 months later.

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Radiology

FDA Hold Letter ResponseFDA Cybersecurity510k
Logo, Envisionit Deep AI

Our Partners Include

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