IAG Announce FDA 510(k) Clearance for Dynamika Platform
IAG, Image Analysis Group are pleased to announce the FDA (U.S. Food and Drug Administration) 510(k) clearance of their proprietary cloud-based software platform DYNAMIKA.
DYNAMIKA is a powerful cloud platform for management, review and automated scoring of imaging data in clinical trials. It has been cleared by the FDA for the display, analysis and post-processing of medical images.
In clinical trials, DYNAMIKA provides the users with the workflow-based Electronic Data Management system to allow for efficient transport, quality control and audit trail of the images.
DYNAMIKA also incorporates a rich collection of image scoring methodologies – both criteria-based (RECIST) and automated routines for quantitative image analysis.
This is a unique all-in-one solution for the imaging data management and image review, which has been praised by many biopharmaceutical sponsors, physicians and radiologists.
At the American Society of Clinical Oncology (ASCO) annual meeting, IAG’s team will be demonstrating efficiency of DYNAMIKA’s data management as well as comparing the ability of the criteria-based scoring systems (like RECIST) with the advanced image analysis methodologies in assessing the efficacy of oncology and immuno-oncology treatments.
Dynamika Version 5.0 is an image processing software package to be used by trained medical professionals with a level of medical expertise (including physicians, radiographers and radiology technicians). The software is compliant with the DICOM standard and is suitable for running on Windows, Macintosh or Linux operating systems. It can run on a standard off-the-shelf workstation and can be used to perform image viewing, processing and analysis of medical images. Dynamika provides both viewing and analysis capabilities of dynamic imaging datasets acquired with MRI, showing the properties of changes in contrast over time. The package may be used to calculate permeability parameters related to the leakage of injected contrast material from intravascular to extracellular space. Parametric maps may be overlaid onto the original image for interpretation. Dynamika Version 5.0 is intended to be used within hospitals and medical clinics. It is licensed and not intended for general public use.
IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. www.ia-grp.com