Senzimes receives CE-MDR approval for new disposable sensor intended for small children
Press release: Uppsala, March 25, 2022. Senzime announces today that the use of the TetraGraph system has been expanded to include small children with the CE-MDR approval of the new disposable and EMG-based TetraSens Pediatric.
Senzime's system for monitoring neuromuscular blockade during and after surgery – TetraGraph – has been CE marked since 2018 and is currently sold in 29 countries worldwide. The small and flexible TetraSens Pediatric broadens the target patient group for the TetraGraph system to also be used on young children.
Studies show that children face the same high risk of complications from the use of paralyzing drugs as adults. Infants and children have also shown large variations and prolonged duration of action after administration of NMB.
Pia Renaudin, CEO at Senzime, comments: "The use of paralyzing drugs in children is steadily increasing. Children are an extra sensitive patient group where it is more difficult to monitor neuromuscular activity during surgery. Our new disposable sensor TetraSens Pediatric helps to improve the monitoring of children during and after surgery.”
Senzime is a Swedish medical device company that develops and markets CE- and FDA-cleared monitoring systems for patients undergoing anesthesia. Senzime’s employees worldwide are committed to the vision of a world without anesthesia related complications. Six out of ten patients that wake up after surgery are not fully muscle recovered and therefor at risk having critical respiratory complications. The TetraGraph system helps anesthesia providers improve patient care and reduce healthcare costs by digitally and continuously measure the degree of neuromuscular blockade under and after surgery. Senzime operates in the worlds leading markets targeting a market opportunity valued in excess of SEK 15 billion per year. The company’s shares are listed on Nasdaq Stockholms main market (ticker SEZI). www.senzime.com