Automatic surgical stitching instrument
|Funding from Vinnova||SEK 300 000|
|Project duration||June 2018 - March 2019|
Purpose and goal
Suturion AB develops and evaluates a suturing device for swift and standardized abdominal closure after surgery. High quality abdominal closure reduces the risk for incisional hernia wich is a large social and economic burden globally. The suturing device minimizes the risk for prick injuries and reduce abdominal closure time wich liberates surgical resources to other patients.
Expected results and effects
Innovativa start-ups phase 1 enabled us to do a regulatory investigation and initiate set-up of the quality management system directed towards CE-registration and FDA-approval. These steps are important for further commercialize the device and to make a multicenter clinical study.
Planned approach and implementation
The project was initiated with a regulatory workshop that identified the pathway towards CE-registration and FDA-approval. The quality management system is organized according outcomes from the workshop by the CTO, CEO and a regulatory expert. We also performed a biocompatibility study and initiated the clinical evaluation study.