Wellumio, a New Zealand-based medical device company engaged in stroke detection technology, has launched a new subsidiary in California, US.
This move will support Wellumio’s US-based clinical trials for its Axana device.
The trials aim to validate the device and bring life-saving technology to stroke teams across the US.
Wellumio aims to advance stroke detection and improve patient outcomes nationwide.
Axana is a portable, lightweight technology that uses Pulsed Gradient Free Mapping (PGFM) to quickly identify stroke-affected brain tissue.
It is designed to empower frontline healthcare workers in emergency departments and intensive care units (ICUs) to make fast, life-saving decisions within the critical golden hour, improving patient outcomes.
Unlike traditional magnetic resonance imaging (MRI), which uses superconducting magnets and large coils, Axana’s technology utilises Pulsed Gradient Free Mapping (PGFM).
Wellumio said this method eliminates bulky components, allowing the device to track the magnetic resonance properties of brain tissue. It also helps in detecting stroke biomarkers, such as molecular diffusion, in a compact, portable design.
Axana’s portability and ease of use make it perfect for bedside applications. It enables rapid detection of stroke damage, offering crucial insights into severity and extent.
This fast information helps prioritise advanced imaging and informs urgent treatment decisions.
The medical device company has also completed pre-submission meetings with the US Food and Drug Administration (FDA), marking progress toward US regulatory approval and preparing for commercial launch.
Wellumio CEO Shieak Tzeng said: “We’ve designed a novel device that is highly portable and significantly faster than traditional MRIs, making it ideal for quick assessments in emergency situations.
“By delivering radial maps of the brain, Axana empowers emergency physicians, neurologists, radiologists, and stroke care team members to rapidly detect strokes and guide critical treatment decisions during the crucial golden hour of care.”
Wellumio has also announced several key appointments to support these efforts and lay the foundation for a successful launch. Additionally, the medical technology firm has several US-based medical advisory board members.
In October last year, Royal Philips and Medtronic Neurovascular forged an advocacy partnership to help expedite access to life-saving treatments.
