Compumedics (ASX: CMP) has collared US Food and Drug Administration approval for its neuroimaging technology, enabling insurers to be billed for the scan.
On Friday, the FDA officially granted 510(K) clearance to Compumedics for its Orion LifeSpan Magnetoencephalography (MEG) single Dewar system.
Compumedics’ MEG is a neuroimaging technique that maps brain activity by recording magnetic fields generated by the brain’s natural electrical currents.
The technology also allows for a dual-helmet system, with one side optimised for adult MEG recordings and the other for children.
“Compumedics is very pleased to have achieved this important milestone for the Orion LifeSpan MEG,” Compumedics chairman and chief executive officer Dr David Burton said.
“Receiving 510(K) clearance from the FDA, whilst expected, it is nevertheless satisfying and validating after all the research and development 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,” he added.
The FDA greenlight for the MEG hardware follows Compumedics’ already approved Orion LifeSpan components including amplifiers, the simultaneous EEG subsystem, and the integrated co-registration, neuroimage processing and source estimation software – CURRY.
This paves the way for the technology to be used routinely in a clinical setting – primarily for epilepsy and pre-surgical brain function mapping.
Installation and first phase commissioning of the Dewar Orion LifeSpan MEG has already been completed at the Barrow Neurological Institute in Arizona.
It is expected installation of the dual-helmet sensing system will be carried out in the coming months and this will be followed up with a FDA application.
According to Compumedics, FDA clearance also enables sites using Orion LifeSpan to bill insurers for MEG examinations.
The company noted each system typically sells for between US$3-4 million (A$4.46-5.95 million), depending on specifications.
“Compumedics continues to actively pursue 40 identified MEG opportunities around the world, with four opportunities substantively advanced,” Dr Burton said.
With Dr Burton anticipating MEG will follow a similar trajectory to MRIs, the company pointed out about 200 MRI systems had been installed by the late 1980s and these were primarily used for research prior to the implementation of billable codes, which became available in the 1990s.
Today, there are about 36,000 MRI machines used around the world, with a further 2,000-3,000 purchased annually.
Compumedics’ share price was up almost 19% to $0.825 in early morning trade.