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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

Fast 510(k) for Breakthrough IVD

FeaturedFast 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 Software Fast 510(k)

FeaturedFast 510(k)510k

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

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AI/ML-Enabled Longitudinal Tumor Tracking Radiology Viewer

FeaturedSoftware DevelopmentImage ProcessingDICOMWeb-App510k

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

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Radiology

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

FDA Hold Letter ResponseAI/ML

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

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Pre-Clinical

Image Processing Pipeline Improvements

Software DevelopmentImage Processing

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

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Radiology

Radify Triage Cybersecurity FDA AI Request Response

FDA Hold Letter ResponseFDA Cybersecurity Remediation510k

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

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Radiology

Medical Image Viewer Guided 510(k)

Guided 510(k)510k

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

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Digital Health

SMART on FHIR App for an ER SaMD

Software DevelopmentWeb-App

Accelerated software design and development for intake software platform

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Radiology

AI/ML Pipeline Support for VC-Backed Startup

AI/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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Radiation Oncology

Mobius Medical Advanced Image Processing Project

Software DevelopmentImage Processing

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

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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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Radiation Oncology

MRI Geometric Distortion Check Algorithm

Software DevelopmentImage ProcessingWeb-App

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

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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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Ear Nose and Throat

OCT Software Development and 510(k) Documentation

Software Development

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

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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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Pre-Clinical

Preclinical Imaging Analysis Platform

Software DevelopmentWeb-App

Accelerated software development compared to prior general-purpose software team

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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.