OEM News, Regulatory

European Regulators OK AI-Enabled Radiology Software

The tool automatically segments the prostate gland in MRI scans and independently identifies pathological changes.

FUSE-AI GmbH’s AI software Prostate.Carcinoma.ai has received EU Medical Device Regulation (MDR) certification. 
 
The software tool helps radiologists by automatically segmenting the prostate gland in MRI scans and independently identifying pathological changes, promising a 30% time saving per patient, according to the company. The software’s integration into existing clinical software systems ensures user-friendliness and preserves radiologists’ familiarity with their work environment. Additionally, radiologists have tested the product for their colleagues in an evidence-based clinical trial.
 
“This AI software is a testament to the interdisciplinary collaboration among scientists, AI developers, and radiologists. Receiving certification is a pivotal step, transitioning preliminary agreements into binding contracts and fully leveraging the software’s capabilities in clinical settings. This milestone substantially lowers investment risks into our company,” FUSE-AI Founder/CEO Matthias Steffen said.
 
The global market for medical image analysis software is estimated to be worth $4.54 billion in value and grow 9.9% annually.
 
The company is now integrates the Prostate.Carcinoma.ai algorithm into its existing radiology software. Prostate.Carcinoma.ai is the spearhead for a suite of AI-powered diagnostic assistance software for various medical indications, positioning FUSE-AI for global clinical presence and making the software a valuable tool in medical diagnostics.
 
FUSE-AI is a Hamburg, Germany-based e-health company founded in 2017 that develops intelligent software solutions.

Add us as a preferred source on Google

Get the latest Medical Product Outsourcing news, insights and analysis in your Google Search and AI experiences.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters