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.
You need a software-development partner for a new or existing medical-device product.
You need to determine the best path to the US market or have other custom regulatory needs.
Don't take our word for it.
Managing Partner
Director R&D at Varian
Founder and Managing Director
CEO of Dionysus Digital Health
Cofounder of AUMI AI
Technical Product Manager - Therapeutic Physics at Mirion Medical
CEO Neuro Spectrum Insights
CEO
Technical Lead at Rology
CTO and Co-Founder at Envisionit Deep AI
CEO of Rology
Associated VP at Varian Medical Systems
CEO of Radical Imaging
Executive Director, Tissue Engineering at Valo Health
Co-Founder at AI Metrics & Chair of Diagnostic Imaging at St. Jude Children's Research Hospital
Co-Founder and Chairman of Retrieve Medical
CEO at SimBioSys
We've helped develop software and achieve FDA clearance on more than 70 projects since we were founded in 2012
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
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
AI/ML engineering and FDA clearance of a radiology AI/ML quantitative imaging SaMD.
Read the case study →Dr. Steven Rothenberg M.D. - Radiology
Time critical responses to FDA's concerns with clearance soon after
Read the case study →Tushar Pandey - Radiology
Over 10x improvement to in-house image-processing GUIs using AI and other optimizations
Read the case study →Nate Bays, PhD - Pre-Clinical
Rapid response to hold letter with major cybersecurity findings. Clearance 3 months later.
Read the case study →Andrei Migatchev - Radiology
Fast 510(k) for a medical image viewer starting with no documentation
Read the case study →Rob Lewis - Radiology
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
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
Accelerated software design and development for intake software platform
Read the case study →Dr. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHT - Digital Health
AI-Enabled radiology SaMD development, 510(k) clearance, and on-going development/maintenance
Read the case study →Dr. Andrew Smith, MD PhD - Radiology
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
Performance constrained image processing and machine-learning algorithm development with web-based user interface.
Read the case study →Mircea Lazea - Radiation Oncology
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
Accelerated software development compared to prior general-purpose software team
Read the case study →Alex Klose, PhD - Pre-Clinical