BPH investee Cortical Dynamics applies for BARM FDA approval
BPH Energy (ASX:BPH) investee Cortical Dynamics has begun the filing process for its BARM technology (brain anaesthesia response monitor) in the US with the filing of an FDA 510K.
The Food and Drug Administration (FDA) is the federal agency of the United States Department of Health and Human Services which regulates the sale of medical device products (including diagnostic tests) in the US, while also monitoring the safety of all regulated medical products.
FDA approval is a necessary precursor for sales of BARM to commence in the US.
Cortical already has achieved both CE (Europe) and TGA (Australian) registration and is currently awaiting final approval of the company’s registration application to the Korean Ministry of Food and Drug Safety.
Having achieved registration in Europe and Australia, one would expect the chances of receiving FDA approval are relatively high.
The US is a large market, and this would be a significant development for Cortical, and indeed BPH given its 16% interest in the group.
Shares in BPH double on back of strong news flow
Cortical Dynamics is finishing the fiscal year in strong fashion, having announced last week that it had entered into a non-exclusive Licence and Co-operation Agreement with Philips Healthcare North America Corp.
The agreement will enable Cortical to interface its BARM into the Philips IntelliVue and Patient Information Center (PIC iX) Monitoring Systems using the IntelliBridge integration product line.
Royal Philips (NYSE:PHG; AEX:PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care.