The clearance was achieved after two years of collaboration with the FDA, with Cortical receiving support from MCRA, a Washington-based company specialising in medical device, diagnostic and biologics services.
BARM version 1 is already approved in Europe, Australia and South Korea.
Designed for use in the operating room and ICU, BARM is a next-generation certified class II personalised Depth of Anaesthesia Monitoring Device and is complemented by a deep learning system/app called CORDYAN (Cortical Dynamics Analytics).
Philips approved the compatibility of the BARM Pec “plug and play” version 1 with its IntelliView operating room monitors.
The corporation has achieved the required prerequisites of the Philips licence and cooperation agreement to claim it as a compatible and “supported device” for Philips patient monitoring systems.
Cortical is collaborating with its partner, the Austrian Institute of Technology, to develop an improved version of BARM. This enhanced version will feature upgrades 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.”
Furthermore, Cortical has named Dr Sunil Nagaraj as its new chief scientist.