UPPSALA, Sweden – Senzime AB today announced that its TetraGraph® neuromuscular monitoring system has received an additional FDA Class II 510(k) clearance. The new FDA clearance follows submission in April 2026 and expands the system’s capabilities, further strengthening the TetraGraph’s competitive advantages.
The new 510(k) clearance includes, among other things, unique capabilities of the next-generation TetraGraph system, and additional innovations that will be introduced over time.
“This FDA clearance is an important milestone for Senzime, enabling broadened competitive advantages of current and future capabilities of the TetraGraph system,” said Philip Siberg, CEO of Senzime. “We continue to pioneer our industry by developing innovations that enhance patient safety, improve clinical workflows, and support more cost-effective care.”
The TetraGraph system is used by anesthesiologists in more than 750 hospitals worldwide to support patient safety during and after surgery. The system uses proprietary algorithms and advanced sensors to accurately monitor neuromuscular function during surgery. This helps clinicians to determine when it is appropriate to intubate patients, optimize dosing of neuromuscular blocking and reversal agents, and assess when patients are ready for extubation and spontaneous breathing after surgery.