- Compumedics (CMP) has received clearance from the U.S. Food and Drug Administration (FDA) for its neuroimaging technology
- The clearance allows for routine clinical use of the MEG devices, mainly for epilepsy and pre-surgical brain function mapping
- Sites using the technology can now routinely bill private and public insurance plans for the examination
- The FDA green light is a significant milestone for the company
- Compumedics says it will open doors to the global markets
- CMP is up 30.6 per cent on the market this afternoon, selling shares for 90.8¢ apiece
Compumedics (CMP) has received clearance from the U.S. Food and Drug Administration (FDA) for its Orion LifeSpan Magnetoencephalography (MEG).
MEG is a neuroimaging technique that maps brain activity by recording magnetic fields produced by electrical currents occurring naturally in the brain.
This technology also allows for a dual-helmet system, with one side for adults and the other for children.
This news follows the successful installation and first phase commissioning of the single Dewer Orion LifeSpan MEG at Barrow Neurological Institute in Phoenix, Arizona.
The FDA clearance allows for routine clinical use of the MEG devices, mainly for epilepsy and pre-surgical brain function mapping. Sites using the technology can now routinely bill private and public insurance plans for MEG examinations.
In the late 1980s, there were about 200 MRI systems installed, like MEG today, these were largely used for research. There are about 36,000 MRI’s installed globally today.
The company believes MEG may follow a similar path.
CEO David Burton is pleased to have achieved this milestone for MEG.
“Receiving 510(K) clearance from the FDA, whilst expected, it is nevertheless satisfying and validating after all the R&D over many years,” he said.
“Much like MRI technology in the late 1980s which transitioned from research to clinical application, we expect MEG to follow a similar trajectory,” he added.
Compumedics is up 30.6 per cent on the market this afternoon, selling shares for 90.8¢ apiece at 1:47 pm AEDT.