EXCELSIOR is a cloud-based imaging software platform cleared with the FDA as a Class II medical device (K#220929), with specific indication for managing ophthalmic and radiological clinical trial data. Consequently, MERIT is organized as a medical device manufacturer, following cGMP.
In 2013, EXCELSIOR received FDA 510(k) clearance as a class 2 medical device for managing ophthalmic clinical trial data. In 2022, the clearance was expanded to include new indications for use such as interpretation and evaluation of radiologic images (CT, MR and PET) in clinical trials.
EXCELSIOR’s image processing platform, and built-in measurement and analysis tools, allow for standardization of images across device manufacturers for consistent measurements and outcomes across multiple devices. Customizable configuration provides flexibility to address the wide range of workflow and data endpoints required for each unique study. The dedicated user roles, integrated query messaging system, and cloud-based service provides 24/7 real-time access and study progress transparency to all trial partners throughout the study timeline.
EXCELSIOR allows immediate transfer of data directly from qualified sites to a central database for review without installing software or configuring firewalls. EXCELSIOR, built specifically for supporting image data collection and management for clinical trials, offers the latest web and imaging technologies for data standardization, analysis, reading, and reporting.