Medical Device AI Experts

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.

Our Services

Software Development

You need a software-development partner for a new or existing medical-device product.

FDA Regulatory Consulting

You need to determine the best path to the US market or have other custom regulatory needs.

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.

Working with Innolitics was a true game-changer for us. Their exceptional expertise in both engineering and regulatory affairs enabled us to speed up our product development and achieve FDA clearance within a year. Innolitics is more than just an engineering firm—they're a trusted partner. I have complete confidence in their technical skills to build things right the first time.
Dr. Steven Rothenberg MD

Dr. Steven Rothenberg MD

Managing Partner

Our FDA submission deadline was just two weeks away, and we had no software or cybersecurity documentation. We feared we would miss the deadline. Then our regulatory team introduced us to Innolitics. Their team swiftly validated our software and prepared the 15 necessary software and cybersecurity documents. They took a pragmatic approach that truly added value. This rapid timeline would have been impossible to meet without a team deeply knowledgeable in software, cybersecurity, AI/ML, and FDA regulations. In the end, we were able to submit on time! Thank you, Innolitics, for your Herculean efforts!
Andrea Cubitt

Andrea Cubitt

CEO of Dionysus Digital Health

We’re grateful to Innolitics for their expert help in getting our product 510(k) cleared. Our team was totally focused on other objectives, so we were excited to learn about the Innolitics Fast 510(k) service. Working with them was smooth, and now we have an FDA cleared product!
Rob Lewis

Rob Lewis

CEO of Radical Imaging

I needed a software development partner to write the software, train the AI, and get FDA clearance. An investor once told me that it would take me $5 million and 5 years to get to where we are now. Innolitics got me here 3 years ahead of schedule and $4 million dollars under budget.
Dr. Andrew Smith, MD PhD

Dr. Andrew Smith, MD PhD

Co-Founder at AI Metrics & Chair of Diagnostic Imaging at St. Jude Children's Research Hospital

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

Dr. Richard Ricci, DDS, MS, FAGD, Dr. Andrea R. Cambria, DDS, FAGD - 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.

Read the case study

Dr. Steven Rothenberg MD - Radiology

Medical Imaging AI DevelopmentSoftware DevelopmentRegulatory StrategyFDA Hold Letter ResponseFast 510(k)FDA Cybersecurity RemediationAI/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.

Read the case study

Andrei Migatchev - Radiology

FDA Hold Letter ResponseFDA Cybersecurity Remediation510k
Logo, Envisionit Deep AI

Our Partners Include

Let's Talk

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.