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.
