FDA Expands 510(k) Clearance of Merit’s Excelsior Software

The FDA has expanded its 510(k) clearance of Merit’s Excelsior clinical trial data workflow management software to include interpretation and evaluation of radiologic images.

The software had previously received 510(k) clearance in 2013 for managing ophthalmic clinical trial data. The expanded clearance will allow clinical trial images from computed tomography, magnetic resonance imaging and positron emission tomography to be managed in the system.

The cloud-based imaging platform collects and manages data and images for clinical trials by transferring files directly from qualified sites to a central database for review without installing software or configuring firewalls.