Companies like yours create
medical device software with Innolitics

OrthoVentions, a medical device startup accelerator partnering with Hospital for Special Surgery, needed FDA regulatory strategy for Gemini—an AI-powered SaMD platform creating 3D joint models from 2D MRI. After finding two other consultants suboptimal, they chose Innolitics for proactive FDA expertise, pragmatic approach that preserved strong existing work, and strategic project management. Innolitics delivered a robust FDA Pre-Submission on time and within budget. The outcome: "They did what they said they were going to do, and they did it within the budget that they said they were going to do. So there were no surprises."

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.

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.

Innolitics partnered with NeuroSpectrum Insights to develop Gyricalc, a diagnostic tool for neurodevelopmental conditions in children as young as two years old. This project showcases our engineering expertise in transforming a research idea into a fully developed web application and highlights our regulatory proficiency in successfully navigating the FDA pre-submission and 510(k) submission processes.

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

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

Guide an engineering team without FDA experience through a 510(k) for a breakthrough in vitro diagnostic (IVD) platform

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

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

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