Companies like yours create
medical device software with Innolitics

This was our first submission at Heartvue.AI, and it was not a simple one. Between the AI/ML performance questions, the PCCP, and several rounds of deficiency responses on tight timelines, there were plenty of moments where we needed more than process management. We needed people who deeply understood both the science and how FDA thinks. Mary and Matt were that, every single time. They caught issues before FDA did, they explained their reasoning clearly, and they were calm and steady. We will be recommending Innolitics to anyone who asks (and probably to some who don't).

We developed the science at WashU Medicine, but reaching patients requires FDA clearance — outside research lab expertise. Partnering with Innolitics, we advanced BEACONPredict from lab code to FDA Breakthrough Device in one submission cycle.

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.

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!

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.

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 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.

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 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.

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.

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.

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!

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.