0000000000519418
AUTHOR
Thilo B. Krueger
Research platform for medical device development to simplify translation to the market
New regulations for medical products complicate research projects for new application fields and translation of innovative product ideas to refundable medical products becomes a high economic risk. All this demands for a CE-marked platform, which offers the possibility to access the recorded data online or even directly the hardware during research applications, to bridge the gap. This paper describes how a CE-marked medical product can be extended by different interfaces to enable basic research or simplify first proof-of-concept studies thus optimizing prototype development in research projects, simplifying the documentation process and reducing the risk for market access.
Postprocessing algorithm for automated analysis of pelvic intraoperative neuromonitoring signals
Abstract Two dimensional pelvic intraoperative neuromonitoring (pIONM®) is based on electric stimulation of autonomic nerves under observation of electromyography of internal anal sphincter (IAS) and manometry of urinary bladder. The method provides nerve identification and verification of its’ functional integrity. Currently pIONM® is gaining increased attention in times where preservation of function is becoming more and more important. Ongoing technical and methodological developments in experimental and clinical settings require further analysis of the obtained signals. This work describes a postprocessing algorithm for pIONM® signals, developed for automated analysis of huge amount of …