Search for content, post, videos

Senzime receives FDA 510k-clearance

Pia Renaudin CEO Senzime

The company’s TetraGraph-system has now received FDA 510k-clearance for use in children with the disposable sensor TetraSens Pediatric.

Senzime can thus broaden the indication for TetraGraph to also monitor infants and young children who have received muscle paralyzing drugs as part of anesthesia, the company states.

Currently sold in 29 countries

Senzime’s system for monitoring neuromuscular blockade during and after surgery – TetraGraph – is FDA cleared since 2019 and is currently sold in 29 countries worldwide. The market introduction of the small and flexible TetraSens Pediatric sensor will broaden the target patient group for the TetraGraph system to include the pediatric population from infants and up.

“The use of paralyzing drugs in children is steadily increasing. Children are an extra sensitive patient group where it is important to monitor neuromuscular activity during surgery. Senzime continues to lead the market and launch innovative solutions that increase patient safety. Our new disposable sensor TetraSens Pediatric creates completely new conditions for monitoring neuromuscular blockade of children during and after surgery,” says Pia Renaudin, CEO at Senzime.

Photo of Pia Renaudin: Senzime