Innolitics - SaMD and AI Experts

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.

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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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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

Managing Partner

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.

Christof Baltes, PhD

Director R&D at Varian

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.

Dr. Jagi Gill, MD

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.

Dr. Ilya Pyatnitskiy, MD

Cofounder of AUMI AI

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.

Mircea Lazea

Technical Product Manager - Therapeutic Physics at Mirion Medical

After spending over $500,000 on other consultants over 5 years who knew how to sell but lacked expertise in execution, I'm delighted to have found Innolitics. Their combination of software engineering expertise, medical device experience, and scientific acumen helped me craft a regulatory strategy and FDA presubmission meeting that allowed me to secure investment and fund additional software development, which they have executed well. I have seen many engineers in my career at J&J and Ethicon and I can say with confidence that Innolitics are many standard deviations ahead of the curve.

Andrew Stewart

CEO Neuro Spectrum Insights

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.

Tim Szczykutowicz, PhD

CEO

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.

Momen Mohamed

Technical Lead at Rology

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.

Andrei Migatchev

CTO and Co-Founder at Envisionit Deep 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

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

CEO of Radical Imaging

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.

Nate Bays, PhD

Executive Director, Tissue Engineering at Valo Health

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

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

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.**

Dr. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHT

Co-Founder and Chairman of Retrieve Medical

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.

Tushar Pandey

CEO at SimBioSys

All Testimonials

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.

Medical Device AI Experts

Our Services

Our Solutions

Initial Regulatory Assessment

Regulatory Strategy

Real 510(k) Example

Fast 510(k)

Guided 510(k)

FDA Cybersecurity Remediation