Compumedics Limited (ASX:CMP) has confirmed US Food and Drug Administration (FDA) approval of its Neuroscan Orion LifeSpan™ Magnetoencephalography (MEG) system.
The approval follows the successful installation and first phase commissioning of the system at the Barrow Neurological Institute in Arizona, USA.
MEG is a neuroimaging technique for mapping brain activity by recording magnetic fields produced by electrical currents occurring naturally in the brain.
Compumedics chairman and chief executive officer Dr David Burton said the company was pleased to achieve this milestone.
He said: “Receiving 510(K) clearance from the FDA, whilst expected, it is nevertheless satisfying and validating after all the R &D over many years.
“Much like MRI technology in the late 1980s which transitioned from research to clinical application, we expect MEG to follow a similar trajectory.”
The FDA clearance now allows for routine clinical use of the single MEG device, primarily for epilepsy and pre-surgical brain function mapping.
“The foundation for commercialisation”
With the FDA approval in place, Compumedics may now enter the lucrative US clinical market with its technology.
Burton added: “It represents a foundation for the commercialisation of our MEG technology.
"This market clearance will allow us to transition from product development to full commercialisation.
“Compumedics continues to actively pursue 40 identified MEG opportunities around the world, with four opportunities substantively advanced.”
Each system will typically sell for around US$3 million to US$4 million, depending on specification.
Additionally, sites using the system may now routinely bill both private and public insurance plans for MEG examinations.
The MEG hardware approval comes in addition to the already approved components offered with the Orion LifeSpan™ by the company.
These include the amplifiers, the simultaneous electroencephalogram (EEG) subsystem; and the fully integrated, state-of-the-art co-registration, and neuroimage processing source estimation software known as CURRY.
Other ground-breaking features of the system include advanced superconducting quantum interference device (SQUID) detectors for unparalleled sensitivity to brain signals; reduced operating cost from zero-loss helium reliquification with 24/7 operation; and a fully integrated low-noise, high-density EEG monitoring system utilising the latest Compumedics/Neuroscan technology.