Cortical receives 510(k) clearance from FDA for BARM system version 1

Philips approved the compatibility of the BARM Pec "plug and play" version 1 with its IntelliView operating room monitors.

RanjithKumar Dharma September 04 2023

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

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.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close