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.

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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.

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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.

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Dr. Steven Rothenberg MD - 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

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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

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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.

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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

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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

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Dr. 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

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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

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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

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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

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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.

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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

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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

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Alex Klose, PhD - Pre-Clinical

Software DevelopmentWeb-App
Logo, InVivo Analytics
Clear All

Microbiology

Fast 510(k) for Breakthrough IVD

Fast 510(k)510kIVD

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

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Radiology

AI/ML Pipeline Support for VC-Backed Startup

Software DevelopmentAI/ML

Software development and devops support for large existing engineering team

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Tooling

DICOM De-Identification Pipeline for CRO

Software DevelopmentDICOM

Custom software development with PACS performance requirements

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Neurology

SaMD for Computer-Aided Detection of Neurological Disorders

Software DevelopmentImage Processing

MATLAB to Python port with performance improvements, documentation, and verification

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Tooling

Simple DICOM Viewer for Patients

Web-AppDICOM

Online tool for patients to browse MR, CT, X-Ray, and Ultrasound images in a browser

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Tooling

FDA MAUDE Database Alerting App

Web-App

Online tool for subscribing to new alerts in the official FDA database

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Tooling

Simple DICOM Viewer for Patients

Web-App

Browse the FDA product code, 510(k), and PMA databases online

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Pre-Clinical

Magnetic Particle Imaging Control and Processing Software

Software DevelopmentImage Processing

Staff augmentation for highly-technical, PhD heavy engineering team

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Tooling

3D Natural Neighbor Interpolation

Open-Source

High-speed python/C++ module for a superior interpolation algorithm

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Tooling

DICOM Standard Browser

Web-AppDICOM

Popular free tool for browsing the main medical imaging standard

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Tooling

MR, CT, and PET Python DICOM Library

Open-SourceDICOM

Python module for extracting data contained in DICOM files

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Radiation Oncology

Radiation Oncology CT Directive Dashboard

Software DevelopmentWeb-App

Custom CT Simulation directive dashboard integrated radiation planning system

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Gastroenterology and Urology

Clinical Decision Support and Intake App

Software DevelopmentMobile

UI and algorithm design and development for Android and web

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Tooling

React Slicer Toolkit

Open-SourceAI/ML

Medical Image Viewer JavaScript and React toolkit

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Tooling

High Dimensionality Algorithm Tester

Open-SourceAI/ML

Testing methodology and an associated Python framework for regression testing algorithms and AI/ML models

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Medtech Insider Insights

Our Medtech tips will help you get safe and effective Medtech software on the market faster. We cover regulatory process, AI/ML, software, cybersecurity, interoperability and more.