BPH Energy’s investee company Cortical Dynamics has secured US Food and Drug Administration (FDA) 510(k) clearance for its flagship Brain Anaesthesia Response Monitor (BARM) system version 1.

BARM technology is a next-generation certified class II personalised depth of anaesthesia monitoring device for usage in the intensive care unit (ICU) and operating room.

The clearance is the result of the two years of the firm’s effort with the US FDA following the initial submission in 2021.

The neurotechnology company was supported by MCRA, a Washington, US-based medical worldwide full-service contract research organisation (CRO) and consulting advisory for medical devices, diagnostics, and biologics.

The 510(k) clearance for BARM version 1 in the US is complemented by existing approvals by South Korea’s Ministry of Food and Drug Safety (MFDS), Australia’s Therapeutic Goods Administration (TGA) and European Union’s Conformité Européene (CE) Mark.

Dutch company Philips certified the BARM Pec “plug and play” version 1 to work with its IntelliView monitors used in operating rooms earlier this year.

Together with its partner AIT (the Austrian Institute of Technology), situated in Vienna, Cortical is developing an improved version of BARM that will incorporate updates to the software, hardware, and firmware.

BPH and Cortical director David Breeze said: “The 510 (k) clearance by the FDA is a major milestone in the development of the Company which lays the foundation for the commercialisation of the BARM system in the USA”.

The neurotechnology company has appointed Sunil Nagaraj as its new chief scientific officer to lead the introduction of the new technology into US markets.

BARM is complemented by Cortical Dynamics Analytics (CORDYAN), a proprietary deep learning system/ app focusing on anesthesiology.