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.

FDA Regulatory Consulting

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

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.

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 M.D.

Dr. Steven Rothenberg M.D.

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

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.
Jagi Gill, MD

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Tushar Pandey

CEO at SimBioSys

Companies like yours create medical device software with Innolitics

We've helped develop software and achieve FDA clearance on more than 70 projects since we were founded in 2012

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.

Read the case study

Dr. Richard Ricci, DDS, MS, FAGD, Dr. Andrea R. Cambria, DDS, FAGD - Dental

Guided 510(k)Software DevelopmentWeb-AppAI/MLImage Processing510k
Logo, Cube Click, Inc.

RadUnity (FDA Cleared DICOM Workflow Engine)

We implemented a data-intensive DICOM image processing system to aid clinical workflows. We built this as a modern web application for ease of use. We prepared a complete 510(k) submission for the device and obtained FDA clearance. Both engineering and FDA clearance were completed within 14 months, starting from the ground up.

Read the case study

Tim Szczykutowicz, PhD - Radiology

Software DevelopmentFast 510(k)Regulatory StrategyFDA Hold Letter ResponseWeb-AppImage ProcessingDICOM510k
Logo, RadUnity

Body Check (FDA Cleared End to End AI/ML SaMD)

AI/ML engineering and FDA clearance of a radiology AI/ML quantitative imaging SaMD.

Read the case study

Dr. Steven Rothenberg M.D. - Radiology

Medical Imaging AI DevelopmentSoftware DevelopmentRegulatory StrategyFDA Hold Letter ResponseFast 510(k)FDA Cybersecurity RemediationAI/ML510kImage Processing
Logo, Body Check

Emergency FDA AI Request Rescue for an AI/ML SaMD Application

Time critical responses to FDA's concerns with clearance soon after

Read the case study

Tushar Pandey - Radiology

FDA Hold Letter ResponseAI/ML
Logo, SimBioSys

Image Processing Pipeline Improvements

Over 10x improvement to in-house image-processing GUIs using AI and other optimizations

Read the case study

Nate Bays, PhD - Pre-Clinical

Software DevelopmentImage Processing
Logo, Valo Health

Radify Triage Cybersecurity FDA AI Request Response

Rapid response to hold letter with major cybersecurity findings. Clearance 3 months later.

Read the case study

Andrei Migatchev - Radiology

FDA Hold Letter ResponseFDA Cybersecurity Remediation510k
Logo, Envisionit Deep AI

Radiology Software Fast 510(k)

Fast 510(k) for a medical image viewer starting with no documentation

Read the case study

Rob Lewis - Radiology

Fast 510(k)510k
Logo, Software Services Firm with First Product

Regulatory Strategy for AI/ML SaMD Suite

Regulatory strategy and submitted a presub to the FDA for a multi-phase pathway for multiple AI/ML algorithms

Read the case study

Ilya Pyatnitskiy, MD - Radiology

FDA Regulatory ConsultingAI/ML
Logo, AUMI ai

Medical Image Viewer Guided 510(k)

Guide an engineering team without FDA experience through a 510(k) for a medical image viewer

Read the case study

Amr Abodraiaa, Momen Mohamed - Radiology

Guided 510(k)510k
Logo, Rology

SMART on FHIR App for an ER SaMD

Accelerated software design and development for intake software platform

Read the case study

Dr. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHT - Digital Health

Software DevelopmentWeb-App
Logo, Retrieve Medical

AI/ML-Enabled Longitudinal Tumor Tracking Radiology Viewer

AI-Enabled radiology SaMD development, 510(k) clearance, and on-going development/maintenance

Read the case study

Dr. Andrew Smith, MD PhD - Radiology

Software DevelopmentImage ProcessingDICOMWeb-App510k
Logo, AI Metrics - Dr. Andrew Smith

Mobius Medical Advanced Image Processing Project

Architectural design, implementation, verification of special image-processing SaMD module that achieved 510(k) clearance

Read the case study

Nathan Childress, PhD, DABR, Christof Baltes, PhD - Radiation Oncology

Software DevelopmentImage Processing
Logo, Varian Medical Systems Mobius 3D

MRI Geometric Distortion Check Algorithm

Performance constrained image processing and machine-learning algorithm development with web-based user interface.

Read the case study

Mircea Lazea - Radiation Oncology

Software DevelopmentImage ProcessingWeb-App
Logo, CIRS (Now Sun Nuclear)

OCT Software Development and 510(k) Documentation

UI design, Custom C++, Qt, Python development, IEC 62304 and FDA software documentation for a successful 510(k) submission

Read the case study

Ryan Shelton, PhD - Ear Nose and Throat

Software DevelopmentAI/MLImage Processing
Logo, PhotoniCare

Preclinical Imaging Analysis Platform

Accelerated software development compared to prior general-purpose software team

Read the case study

Alex Klose, PhD - Pre-Clinical

Software DevelopmentWeb-App
Logo, InVivo Analytics

Our Partners Include

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