FDA clearance for Swiss medical AI software

AI Medical’s objective is to advance the quality, safety and efficiency of patient healthcare by employing advanced, AI-driven software tools for radiology image processing. The startup, founded in 2021, developed a software solution called Jazz, which holds the European CE-mark and received FDA clearance this year.

Jazz integrates seamless into the clinical workflow of radiologists and radio-oncologists for assessments of magnetic resonance follow-up scans. The software makes repetitive, time consuming, low-level tasks obsolete for clinicians, by performing lesion annotations, volume measurements and counts automatically. The software can volumetrically quantify and track lesions  (any damage or abnormal change in the tissue of an organism) over a long period of time and provide data on statistical lesion evolution. With Jazz, high-quality radiology reports can be produced faster and with higher accuracy compared to standard approaches. This allows radiologists and radio-oncologists to allocate more of their time to efficiently assess the generated images and translate this information into precise diagnoses. An annual license can be acquired for the software.

The recent FDA clearance of Jazz has been a pivotal step for AI Medical and a substantial validation of AI Medical’s product, underlining their credibility and quality. Christian Federau, Founder and CEO of AI Medical, emphasized the significance of this milestone in the company’s strategy moving forward: “We are very happy about the recent FDA clearance. This is an important step to reach many more clinicians and research institutes that can benefit from our software”.

To achieve FDA clearance, several performance studies involving hundreds of participants were conducted. The FDA requires US-data as well as multi-centric data. Thus, while most studies took place in Europe, some included locations in the US and other parts of the world, such as Europe and Australia.

The success of Jazz and AI Medical as a startup is a result of over 15 years of experience in neuroradiology and two years of dedicated software development. The product is currently available in the market with the first customers incorporating it in their workflow. AI Medical is collaborating with renowned medical institutions, such as the MD Anderson Cancer Center in Houston, Stanford University and Unispital Zurich.

AI Medical is not resting on its laurels. The company is working on expanding its customer base, focusing on radiologists, radio-oncologists and oncologists, not only in Europe and the US, but worldwide. A business expansion to the US is also planned. The six-head team is also developing more software solutions, widening the applicability of their products to a broader group of clinicians. The company has also developed a free medical image anonymization software called Adage, helping researchers worldwide with this important task. AI Medical is rapidly advancing neuroradiology diagnostics, enhancing patient care, and enabling clinicians to refocus their work on saving lives.


(SR)