Testimonials

We came to Innolitics with a novel AI prognostic tool for breast cancer risk assessment and little clear regulatory path. Within weeks, they submitted a presub and a breakthrough device designation, both which added clarity to our clinical validation strategy and granted us breakthrough designation respectively. The team identified that our device would need to go the De Novo route and walked us through every implication. But they didn't stop there. They saw the potential for Breakthrough Device Designation and built a compelling case for why our technology met FDA's criteria. The quality of that submission was exceptional, thoroughly researched, clearly argued, and backed by deep knowledge of AI/ML regulatory precedents. The Pre-Sub process was where Innolitics really proved their value. They prepared our Q-Submission package, coordinated with FDA, and ran the meeting with us. FDA's feedback was direct and actionable, which meant we weren't wasting time or money chasing the wrong pathway. That alone saved us months and probably six figures in misdirected effort. What impressed us most was how they handled complexity without creating confusion. They reviewed our clinical protocols, identified gaps in our validation datasets, helped us understand special controls for De Novo submissions, and gave us a realistic timeline for market access. Every deliverable was thorough, on time, and written in a way that both our clinical team, business stakeholders, and FDA could understand.

Before working with Innolitics, I struggled to find a partner who understood both AI regulatory requirements and the cybersecurity expectations our device needed to meet. I spoke with several consultants, but none could cover the full scope. Every option seemed to push more work back on us, and the whole thing was starting to feel like a “do it yourself” regulatory project. If we had stayed on that path, we would have missed a narrow window of opportunity. Competitors were moving fast, and delaying our regulatory plan would have given them room to enter the market first and capture early share. Innolitics changed the trajectory. They built our regulatory strategy, prepared the pre-submission, and helped us secure Breakthrough Device Designation.

Our first FDA clearance was monolithic — every component submitted as one device. When we needed to clear a second AI indication, we assumed we'd have to re-submit the entire platform. Innolitics saw something we didn't: a modular regulatory architecture that isolated the new CNN as the only component under review. That single insight saved us months of redundant documentation and positioned every future tumor type as a lightweight module swap. We submitted in September 2025 and cleared in December — 3-month review, zero major deficiencies. I've worked with regulatory consultants before. Innolitics is the first one that understood our software well enough to design a regulatory strategy from the architecture itself.

We likely wouldn't have received our Breakthrough Device Designation without Innolitics. When FDA initially pushed back, they quickly understood the concerns and responded with clear, well-supported data. Their expertise in software, medicine, and FDA's AI/ML expectations made a decisive difference in the outcome.

I learned more from an hour-long Innolitics sales call than an entire paid engagement from other consultants.

7 weeks to submission and 6 months to FDA clearance. Innolitics delivered exactly what we needed. They took ownership of the entire DHF and 510(k) package—documentation, cybersecurity, risk management, the works. When we hit internal roadblocks, they found ways to keep us moving. When scope decisions needed to be made fast, they made the right calls. Fast, thorough, no surprises, and full service. That's how regulatory consulting should work!

We came to Innolitics with a complex AI/ML CADx algorithm and an aggressive timeline. Honestly, we weren't sure it was possible.
Yujan and the Innolitics team turned that assumption upside down. Through their leadership, the combined Innolitics, Lunit, and Volpara Health team delivered a complete submission package—DHF, software documentation, clinical performance assessment, the full eSTAR—in 13 weeks!
What impressed me most wasn't just the speed. It was how they handled the complexity—both technical and organizational. Our device uses AI algorithms for diagnosis, which presented unique regulatory challenges. We also had a multi-national, cross-functional team that needed coordination across time zones and disciplines.
The Innolitics team managed all of it. They knew exactly how to position the device, which predicates to target, and how to draw the medical device versus MDDS boundaries in a way that held up under scrutiny. Most importantly, they structured the technical documentation so FDA reviewers could actually understand what we built without getting lost in the ML weeds.
That combination—deep regulatory knowledge, technical fluency, and the ability to keep a complex team moving in the same direction—is rare. Most consultants have one or two of those. Innolitics have all three. They didn't cut corners. Every deliverable was thorough, well-written, and backed by their deep knowledge of medicine, software engineering, and FDA expectations.
If you've got a sophisticated AI/ML device and need full service regulatory expertise that moves at the speed and certainty, Innolitics is the only call worth making.

I am happy to have "roped in" Innolitics into our medical device journey. Their ability to break down complex technical jargon into actionable insights is incredible. I have come to trust their business, technical, and regulatory sense—and so has the FDA so far. I recommend them to anyone looking for a one stop SaMD shop.

Innolitics are more than a group of top SaMD engineers and reg consultants—they are trusted advisors and are like family. They are a one stop shop for AI/ML algorithm R&D, full stack web development, and FDA regulatory clearance. We built SmileDx, a dental CADe from scratch all without needing to raise external funding and within a reasonable timeframe.

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.

Innolitics played a vital role in the development of our software according to our quality management system, as well as the establishment of our engineering team. Their contributions were integral to fostering a culture of excellence for our complex, software-only medical device. We have had the pleasure of collaborating with them since 2018 and wholeheartedly advocate their services.

The Innolitics team was professional, efficient, and creative—as I would expect from a company founded by UT BME Alumni. They were able to make quick progress on a challenging software problem and our team has been able to maintain and iterate on the software they developed for us.

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.

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!

We engaged Innolitics as a software partner for our AI/ML-enabled radiology application. Their knowledge of AI/ML deployments, DICOM, and FDA regulations added a lot of value on a tight pre-seed budget. We’d definitely recommend them for their niche expertise in medical-device AI/ML.

With updated cybersecurity requirements rolled out during our recent FDA submission, we found ourselves looking for an experienced partner to help us navigate this new environment. We reached out to Innolitics, and they were able to quickly assess our device, develop a strategy, and meet with FDA to find a path forward. Their strategic involvement guided us toward an approach that satisfied the FDA and saved us significant upfront and on-going effort. Innolitics' combination of software and FDA regulatory expertise was invaluable.

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.

I worked with Innolitics to develop an application that analyzes MR images of our geometric distortion phantoms. It was a quite challenging image-processing project. In the end my company and Innolitics team were able to meet the challenge and built a quality web UI and a robust analysis pipeline. Innolitics seems like a company that is run by engineers who care about doing quality work.

I engaged Innolitics to develop a companion app for a COVID testing kit sold directly to users. The app's purpose was to walk people at home through using the test kit. Innolitics was a pleasure to work with. They worked systematically, beginning with a planning phase to collect and clarify our user needs and requirements and ending with thorough V&V and documentation. I’m proud of the app we built together and would certainly work with them again.

After spending $500K over five years on consultants who knew how to sell but couldn't execute, Innolitics took us from concept to FDA clearance in under 18 months for a first-of-its-kind MRI neuroimaging device. When FDA questioned our original approach, they adapted without losing momentum. We submitted on schedule and cleared in 4.5 months. I've seen many engineers at J&J and Ethicon — Innolitics is many standard deviations ahead of the curve.

Working with Innolitics has been a fantastic experience. Their technical and regulatory expertise is exceptional—it's not just programming; it's science combined with a deep understanding of FDA regulations. Interacting with their team feels like collaborating with fellow scientists who navigate the complexities of regulatory compliance effortlessly. Their mastery in detailing the ends of the slice ranges (they'll know what I mean) and guiding us through the FDA process has been impressive. I've recommended them multiple times and will continue to do so.

Collaborating with Innolitics was seamless and productive. Medtech OS resonates with the essence of being crafted by engineers for engineers. The depth of their guidance, peppered with detailed examples, was not just helpful; it was indispensable for our journey.

We really enjoyed working with Innolitics in reviewing our cybersecurity related documentation and compiling a response to the FDA. We were particularly impressed with their knowledge and expertise in the field, and quick turn-around times to our queries. We look forward to working with Innolitics on future projects.

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.

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.

I am superbly impressed by the team at Innolitics. They were able to create a complex medical web application on efficiently and with high quality standards. I was not only impressed with their technical know-how, but also by their excellent communication skills.

I retained Innolitics to create a demonstration app for Android and iOS platforms. They created an elegant design that resulted in a project that was easy to understand and support. I was very impressed by their speed and efficiency, I will definitely be hiring them again.

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.

We commissioned Innolitics to build a dashboard that integrated with our radiation-oncology EMR. Their team’s clinical experience greatly simplified communication and their perceptive questions and suggestions helped us arrive at a better set of requirements for the project. The final result was clean, easy for our doctors to use, and has already improved the efficiency of our workflow.

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!

We partnered with Innolitics to improve and update our team’s analysis software. They have diligently worked to add new features and address the troubled areas of the code to both improve its efficiency, as well as its usability. They work independently solving problems and handling difficult coding situations to deliver quality changes and improvements. These improvements have streamlined our code into a more powerful and concise use interface.

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. The Innolitics team is efficient, fair, and highly ethical. They are an absolute pleasure to work with.

The work conducted by Innolitics to complete a complex software port of a core module of our clinical product was outstanding. The clinical product must by cleared by the FDA, and as such, we needed the highest quality workmanship, and close collaboration with a dispersed team. Innolitics performed exceedingly well in gathering requirements, researching, developing and implementing a design, and providing test modules and documentation. Their team's understanding of medical imaging analysis software, and FDA quality processes, was key to the success of the project.

I have really enjoyed working with the Innolitics team. We had originally enquired about the Innolitics DICOM conformance statement consulting but expanded them to augment the data engineering team. They helped build out a complex ETL pipeline for AI/ML and helped build out accompanying SOPs for regulatory compliance. They treat our product as if it was their own and integrate seamlessly with our in-house engineering team. Their breadth of knowledge in technical and regulatory matters has helped our team meet deadlines.

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.

We needed a team that would get it done right the first time and independently. As a physician, I was delighted to work with another physician engineer on the team that was able to implement complex clinical workflows with very little input from me or my team. Innolitics delivered ahead of schedule and exceeded expectations. Every step of the way, Innolitics demonstrated why they’re leaders in medical software development.

We recently got FDA cleared and Innolitics' responses were absolutely clutch to craft the strategy that finally worked. Unlike other consultants, who wanted us to do more work and spend more money on clinical testing, Innolitics found a path of least resistance using a combination of our existing validation and thoughtful responses to FDA. We received the best Christmas present ever – our 510(k) clearance letter.

Thanks to Innolitics, we were able to complete the software documentation for our 510(k) in just 4 months. They flew onsite to absorb how our software worked and provided detailed guidance. Without Medtech OS, training, and support, I can easily imagine the process taking 12 months. Our engineering team was able to focus on feature development instead of being bogged down with documentation. We tried three different consultants before finding Innolitics. None of them could deliver. Innolitics took the reins and made it happen. I don’t see how we would have completed our 510(k) without them.