FDA grants 510(k) clearance for MIC’s Sickbay clinical platform

2 June 2015 (Last Updated June 2nd, 2015 18:30)

The US Food and Drug Administration (FDA) has authorised Medical Informatics (MIC) to sell Sickbay clinical platform and three applications in the country.

The US Food and Drug Administration (FDA) has authorised Medical Informatics (MIC) to sell Sickbay clinical platform and three applications in the country.

The FDA 510(k) clearance classifies Sickbay clinical platform and MIC's patient monitor, patient alarm data and alarm analytics dashboard applications as Class II medical devices developed for clinical use.

Medical Informatics CEO Emma Fauss said: "FDA clearance of our Sickbay clinical platform and the first series of applications is a significant achievement for our team.

"The Sickbay clinical platform serves as a data collection, aggregation and transformation engine, and applications on it provide patient-specific analytics in near real-time to clinicians through a secure web-browser interface."

"This step forward validates our vision of helping transition data into action for stakeholders across an organisation, making sure the right information gets to the right person at the right time.

"It positions Sickbay to be the enterprise platform to deliver active patient monitoring and patient-specific analytics solutions that can empower clinicians, reduce healthcare costs, and improve patient care to hospitals across the US."

The Sickbay clinical platform serves as a data collection, aggregation and transformation engine, and applications on it provide patient-specific analytics in near real-time to clinicians through a secure web-browser interface.

Designed to re-display, in near real-time, signals from a patient's bedside monitor and devices in a web-browser for remote viewing in clinical environments, the patient monitoring application allows integration with other third party technologies for the display of physiological data with other relevant patient information.

Alarm management dashboards provide up-to-date surveillance of the alarm environment, while enabling clients to track changes as improvements are being made.

Advanced alarm analytics such as time-in-alarm and time-in-alarm-flood are also calculated and displayed through the web-based interface.