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FUSE-AI GmbH, an innovator in artificial intelligence for radiology, have announced its AI software "Prostate.Carcinoma.ai" has received EU Medical Device Regulation (MDR) 2017/745 IIa certification. As of January 2024, the company is authorised to distribute its software as a medical product.
"Prostate.Carcinoma.ai" significantly aids radiologists by automatically segmenting the prostate gland in MRI scans and independently identifying pathological changes, promising a 30% time saving per patient. This efficiency translates into considerable financial benefits for radiological clinics and practices, fueling strong interest in the deployment of the AI algorithm. 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," stated Matthias Steffen, Founder and CEO of FUSE-AI.
This favourable development for "Prostate.Carcinoma.ai" coincides with a forecast that predicts the global market for medical image analysis software to reach a value of $4.545 billion by 2023, with a Compound Annual Growth Rate (CAGR) of 9.9 percent.
At Arab Health in Dubai, one of the most significant healthcare fairs in the Middle East, FUSE-AI will therefore present its product "Prostate.Carcinoma.ai" and its reseller distribution strategy from January 29 to February 1, 2024.
FUSE-AI's distribution strategy is also one of its key sales arguments. The company integrates the AI algorithm into existing radiology software. Manufacturers and providers of radiology software (PACS) already have contracts with clinics and practices and act as resellers. This enables FUSE-AI to optimally leverage the multiplier effect and reach a large number of clinics at once.
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 an indispensable tool in medical diagnostics.