Medical Informatics (MIC) announced the FDA approval for sale in the US, the company’s product Sickbay Clinical Platform and three applications: Patient Monitor, Patient Alarm Data and Alarm Analytics Dashboard.
The products have FDA 510(k) clearance, which classifies them as Class II medical devices developed for clinical use.
"FDA clearance of our Sickbay Clinical Platform and the first series of applications is a significant achievement for our team. This step forward validates our vision of helping transition data into action for stakeholders across an organization – making sure the right information gets to the right person at the right time," says Emma Fauss, CEO.
MIC focuses on clinical data transformation to provide actionable information to clinicians for improved quality of care.
At the core of MIC’s technology and services is the Sickbay Clinical Platform, which serves as a data collection, aggregation and transformation engine. Applications run on the Sickbay Platform and provide patient-specific analytics in near real-time to clinicians through a secure web-browser interface.
The Patient Monitoring application re-displays, in near real-time, signals from a patient’s bedside monitor and devices in a web-browser for remote viewing in clinical environments. Because the application is web-based, it 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 and allow clients to track changes in alarms as improvements are made. Advanced alarm analytics are also calculated and displayed through the web-based interface. Examples of analytics include time-in-alarm and time-in-alarm-flood.
The Patient Alarm Data application provides intelligent analytics and alarm summaries for individual patients to clinicians. This information is utilized to establish a patient baseline and set appropriate alarm limits that are tailored for each individual patient.