Senzime applies for FDA approval for a new single-use sensor for children

Press release: Uppsala, February 23, 2022. Senzime today announces that they have submitted an application to the US Food and Drug Administration (FDA) for approval of their new single-use sensor for children

Senzimes digital system for monitoring neuromuscular blockade, TetraGraph, with its single-use sensor TetraSens is approved for the American market since 2019. A flexible small single-use sensor for young children, TetraSens Pediatric, has been developed, and for which the company now has applied for FDA approval.

Studies show that children are at as high risk of complications from the use of paralyzing drugs as adults[1]. The fact that nearly six out of ten patients have residual block when they are awakened after surgery is a risk that can be prevented by monitoring with a precise and quantitative monitor.

Pia Renaudin, CEO at Senzime, says: " The use of paralyzing drugs in young children is steadily increasing and is now used in a quarter of all pediatric surgeries. Thanks to our innovative R&D team, we are now able to provide a single-use disposable sensor specially developed for children. This sensitive patient group has particularly strong incentives to monitor digitally, objectively, and accurately, which our TetraGraph system enables.

[1] J Klucka et al, Residual neuromuscular block in paediatric anaesthesia

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