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 be the FDA (K153014) 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

Innolitics has been invaluable in developing some components of our cloud-based analysis software for preclinical imaging. They expertly implemented an AI tool for the analysis of DICOM data and helped us with training and optimizing a prototype neural network. Their developers work independently, handling complex challenges with ease, and deliver top-quality results. It's been a pleasure working with the dedicated and professional team at Innolitics, and we highly recommend their services.

Alex Klose, PhD
CTO and Co-Founder at InVivo Analytics

"During a presub, the FDA acknowledged 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"

Ilya Pyatnitskiy, MD
Cofounder of AUMI AI

"I needed a software development partner to write the software, train the AI, and get FDA clearance (K202229). An investor once told me that it would take me $5 million and 5 years but Innolitics got me here 3 years ahead of schedule and $4 million dollars under budget."

Andrew Smith, MD PhD
Cofounder at AI Metrics

"We recently got FDA cleared for an AI/ML SaMD and Innolitics' responses were absolutely clutch to craft the strategy that finally worked. Unlike other consultants, who wanted us to spend more money on clinical testing, Innolitics found a path using our existing data we received the best Christmas present ever – our 510(k) clearance letter"

Tushar Pandey
CEO at SimBioSys

"Innolitics is an incredible partner and consistently surpasses our expectations. They have an extremely agile team, adapting to our needs across back-end and front-end tasks seamlessly. When we needed support around ISO 62304 compliance for FDA requirements, they jumped right in and provided us compliant documentation. They also assisted us as we developed a regulatory strategy around FDA Cybersecurity and HIPAA Compliance (K191804). The Innolitics team is efficient, fair, and highly ethical. They are an absolute pleasure to work with."

Ryan Shelton, PhD
CEO and Co-Founder of PhotoniCare