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.

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Our Services

Software Development

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

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FDA Regulatory Consulting

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

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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.

They were proactive, informative, and very well-versed in the regulatory challenges of AI in medical imaging… Unlike competitors, who sometimes take a blanket approach, Innolitics didn't throw the baby out with the bathwater. They recognized the good work already done and built upon it… We reviewed other capable firms, but none showed the same depth of understanding of the rapidly evolving landscape of AI and regulatory requirements. Their proactive stance with the FDA gave us confidence that we were in the right hands, compared to competitors who seemed more reactive.

Jagi Gill

Founder and Managing Director

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

CEO of Dionysus Digital Health

During a presubmission meeting, the FDA acknowledged that Innolitics were "extremely advanced" in their understanding of the regulations. The FDA essentially concurred with all of Innolitics' advice, demonstrating a deep understanding of the regulations, even in the face of ambiguous topics such as CADe vs non-CADe. They expertly, and politely, navigated the FDA call with our best interests in mind while fostering a collaborative exchange with the agency.

Ilya Pyatnitskiy, MD

Cofounder of AUMI AI

Innolitics' team epitomized proficiency, professionalism, and precision. Their expertise extends beyond FDA regulations, encompassing intricate facets of DICOM, radiology workflows, and adept software engineering. Venturing into this without their support would have potentially stretched our timeline to 9 months or more. Earning the FDA clearance (K231385), for us, is more than just an accomplishment; it's a monumental milestone.

Amr Abodraiaa

CEO of Rology

Innolitics's engineers seamlessly integrate with our existing team. They’ve consistently produced high quality work while helping us solve technical problems in the medical imaging space. In particular, they spearheaded development of a large module that extends our existing product suite. This module has since been cleared by the FDA and is live at hospitals around the world. Their work on the module involved software development, researching various image processing algorithms, analysis of these algorithms against real-world data, and writing detailed technical documentation of the system that justified its approach to the FDA.

Nathan Childress, PhD, DABR

Associated VP at Varian Medical Systems

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.