Senzime’s Next-generation TetraGraph system receives regulatory approval in Japan

Uppsala, Sweden – December 17, 2025 – Senzime AB (publ.) today announced that its Next-generation TetraGraph^® system has received regulatory clearance for sale in Japan from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The approval enables further commercialization of Senzimes products in one of the world’s largest healthcare markets. In connection with the approval, Senzime received the first order for 80 Next-generation TetraGraph monitors for delivery to Japan in the fourth quarter of 2025.

Senzime entered the Japanese market in 2019 in partnership with Fukuda Denshi, a global leader in patient monitoring systems. Since then, hundreds of Japanese hospitals have adopted Senzime’s TetraGraph technology to monitor patients’ neuromuscular function during surgery.

The PMDA approval of the next-generation TetraGraph system represents a significant step in Senzime’s strategy to drive continued revenue growth through broader market penetration, system upgrades, and expected higher utilization rates.

“This approval is a key milestone for us in Japan. Our partner Fukuda Denshi has extensive local market reach and a very strong platform to drive continued growth. Combined with recently updated Japanese clinical guidelines that reinforce the use of quantitative neuromuscular monitoring, we are excited to further expand our footprint in the large Japanese market,” said Philip Siberg, CEO of Senzime.

Senzime has a long-standing partnership with Fukuda Denshi, which is responsible for commercializing the TetraGraph portfolio in the Japanese market, as well as the Fukuda HN-100 integrated NMT module based on TetraGraph technology. The Japanese market consists of approximately 15,000 operating rooms and nearly 3 million major surgical procedures performed annually, underscoring the revenue potential for Senzime’s expanding product portfolio.