Company Interview / EMVision's "brainwave" a step closer towards FDA approval

Scott Kirkland, CEO of EMVision joined ausbiz.

The medical device maker has activated five out of six sites in its pivotal brain scanner trial, a major step toward FDA approval of its portable “emu” device. The trial, running across top-tier stroke centres in the US and Australia, targets up to 300 stroke patients over 6–12 months.

Mount Sinai in New York is the latest site to begin patient recruitment, while the sixth site is pending final approval. The company is also kicking off a Continuous Innovation Study in Brisbane and Newcastle, focused on stroke and traumatic brain injury patients.

EMVision’s bedside scanner uses non-ionising radiation to provide rapid neurodiagnostic insights without needing traditional CT or MRI scans—positioning it as a game-changer for stroke care in emergency settings.

Scott discussed EMVision's next steps with the First Responder program, as well as market opportunities for medical devices.