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.
Dr. Richard Ricci, DDS, MS, FAGD, Dr. Andrea R. Cambria, DDS, FAGD - Dental
AI/ML engineering and FDA clearance of a radiology AI/ML quantitative imaging SaMD.
Dr. Steven Rothenberg MD - Radiology
Rapid response to hold letter with major cybersecurity findings. Clearance 3 months later.
Andrei Migatchev - Radiology
Radiology
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 →Radiology
Time critical responses to FDA's concerns with clearance soon after
Read the case study →Pre-Clinical
Over 10x improvement to in-house image-processing GUIs using AI and other optimizations
Read the case study →Microbiology
Guide an engineering team without FDA experience through a 510(k) for a breakthrough in vitro diagnostic (IVD) platform
Read the case study →Radiology
Fast 510(k) for a medical image viewer starting with no documentation
Read the case study →Radiology
Regulatory strategy and submitted a presub to the FDA for a multi-phase pathway for multiple AI/ML algorithms
Read the case study →Radiology
Guide an engineering team without FDA experience through a 510(k) for a medical image viewer
Read the case study →Digital Health
Accelerated software design and development for intake software platform
Read the case study →Radiology
Software development and devops support for large existing engineering team
Read the case study →Tooling
Custom software development with PACS performance requirements
Read the case study →Radiology
AI-Enabled radiology SaMD development, 510(k) clearance, and on-going development/maintenance
Read the case study →Neurology
MATLAB to Python port with performance improvements, documentation, and verification
Read the case study →Radiation Oncology
Architectural design, implementation, verification of special image-processing SaMD module that achieved 510(k) clearance
Read the case study →Tooling
Online tool for patients to browse MR, CT, X-Ray, and Ultrasound images in a browser
Read the case study →Tooling
Online tool for subscribing to new alerts in the official FDA database
Read the case study →Tooling
Browse the FDA product code, 510(k), and PMA databases online
Read the case study →Radiation Oncology
Performance constrained image processing and machine-learning algorithm development with web-based user interface.
Read the case study →Pre-Clinical
Staff augmentation for highly-technical, PhD heavy engineering team
Read the case study →Tooling
High-speed python/C++ module for a superior interpolation algorithm
Read the case study →Tooling
Popular free tool for browsing the main medical imaging standard
Read the case study →Tooling
Python module for extracting data contained in DICOM files
Read the case study →Ear Nose and Throat
UI design, Custom C++, Qt, Python development, IEC 62304 and FDA software documentation for a successful 510(k) submission
Read the case study →Radiation Oncology
Custom CT Simulation directive dashboard integrated radiation planning system
Read the case study →Gastroenterology and Urology
UI and algorithm design and development for Android and web
Read the case study →Pre-Clinical
Accelerated software development compared to prior general-purpose software team
Read the case study →Tooling
Medical Image Viewer JavaScript and React toolkit
Read the case study →Tooling
Testing methodology and an associated Python framework for regression testing algorithms and AI/ML models
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