Vienna – ImageBiopsy Lab is proud to announce that we received FDA clearance for our first MSK-platform based AI-algorithm.
This makes us the first Austrian digital health company to be cleared by the FDA to commercially offer our deep tech algorithm to US radiologists, supporting their workflow with the power of AI.
Our KOALA (Knee Osteoarthritis Labelling Assistant) software is full PACS-agnostic and can be deployed within any operating environment. The device does not interact with the patient directly, thus only serves as a standby solution in the background and serves as a secondary opinion to the MSK Radiology specialists and/or orthopaedic specialist. By providing information that is already available upon reading the x-ray study, we aim to create an actual value to the physicians in their day-to-day environment without interrupting the workflow. To quote a chairman of radiology: “You gave me the insight on the patient without having to change my routine. The information I require is already there and I can focus more on the patient myself.”
It is our goal to positively impact the quality of care and patient satisfaction, all within the existing clinical environment. We at ImageBiopsy Lab strongly believe that AI has the power to increase consistency of radiographic readings and provide reliable output measures to patients.
Every single person that was involved during process of obtaining our first FDA clearance deserves credit for this amazing achievement. The great team that stands behind ImageBiopsy Lab is using this milestone as confirmation for their hard work and a motivation to find and create additional FDA-cleared solutions for everyday challenges in MSK radiology.
For more information about our milestone accomplishment, check out our news article.