She is a graduate of the master’s program “Applied Technologies for Medical Diagnostics” (ATMD), which is offered jointly by the Upper Austrian University of Applied Sciences and the Upper Austrian University of Applied Sciences for Health Professions. With her diploma thesis, she made it among Austria’s best at universities of applied sciences and was awarded the prize of the Ministry of Science. With her work, she laid the foundation for the regulatory approval process for a new 3D ultrasound computer tomograph (USCT), which will significantly improve breast cancer screening.
A 3D USCT method developed at the Karlsruhe Institute of Technology in Germany is a new technique for imaging breast tissue and is set to revolutionize breast tissue diagnostics and breast cancer screening in the future. The device is currently in the process of being introduced to the medical device market. A crucial part of the approval process of any medical device is the assessment of the safety architecture. This is where Hofbauer’s excellent master’s thesis picked up.
Putting it through its paces
A comprehensive assessment of the clinical, hygienic and safety aspects in their analysis resulted in optimization recommendations and enabled the “presumption of conformity”. This means that the safety and performance requirements are likely to be met. As a result, the USCT-III device is prepared for CE marking, which is the prerequisite for marketing the product.
Michaela Hofbauer initially studied radiology technology at the University of Applied Sciences for Health Professions in Upper Austria and then worked at the Brothers of Charity hospital in Linz. She increasingly focused on the technologies and processes used in radiology, which led her to pursue a master’s degree. “This builds a bridge between medical technology and the technologies in medical diagnostics,” explains co-head of the degree program Martin Zauner from the Upper Austria University of Applied Sciences in Linz.
Hofbauer himself was fascinated by the novelty of the technology. She was attracted by the “complex and wide-ranging work assignment, which included all the regulations for approval”. “The ATMD course was the perfect basis for this challenge. I was able to apply the clinical knowledge I had acquired and put my knowledge of medical device regulations and electrical engineering to the test in preparation for approval,” emphasizes the 29-year-old graduate.
After graduating from the Mühlviertel region, her professional path led her straight into medical technology. She is now Clinical Product Manager at GE Healthcare’s global headquarters for OB/GYN ultrasound in Zipf.
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