Cardiex (ASX:CDX) has announced that the Therapeutic Goods Administration has approved its CONNEQT Pulse arterial health monitor for use in Australia.
The monitor was recently approved by the US Food and Drug Administration (FDA).
The Pulse is a clinical-grade vascular biometric monitoring device designed for use in both clinical and remote patient monitoring settings, as well as at-home setting. It enables the capture of a broad range of arterial health biomarkers, including central blood pressure and arterial stiffness, which are key indicators for cardiovascular risk and vascular health.
Cardiex said it will begin exploring commercialisation opportunities in Australia with an initial focus on pharmaceutical, research and clinician markets. These sectors represent early entry points for the integration of the Pulse into specialist use cases across clinical trials and cardiovascular disease management care.
Cardiex CEO Craig Cooper said, “TGA approval of the Pulse is another milestone for Cardiex as we expand our regulatory and commercial opportunities. This approval reflects our commitment to delivering advanced cardiovascular solutions to global healthcare markets. While the U.S. remains our primary focus at this stage, we’re excited to begin laying the foundation for growth in Australia.”