We are excited to share that our Inflation Device Kit has officially obtained PMDA (Pharmaceuticals and Medical Devices Agency) registration in Japan, one of the world’s most regulated and quality-driven medical markets.

This achievement reflects our commitment to:

• Meeting global standards for safety, quality, and clinical effectiveness

• Investing in regulatory excellence to expand our global footprint

• Bringing trusted cardiovascular tools to healthcare professionals worldwide

With PMDA registration now complete, our inflation devices are being introduced to select Japanese hospitals and distributors. Initial responses from clinicians emphasize:

• High accuracy and pressure control

• Superior build quality and ergonomics

• Smooth performance under demanding cath lab environments

We’re proud to contribute to Japan’s advanced interventional ecosystem and to support local physicians in delivering outstanding cardiovascular care.