Thursday, June 27, 2024
MCRA, a prominent independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm, is proud to announce its role in helping CamDiab's artificial pancreas software, CamAPS FX, achieve U.S. Food and Drug Administration (FDA) clearance.
CamDiab engaged MCRA's Digital Health and Quality Assurance experts to assist with the FDA submission process for the CamAPS FX app. Due to the software's nature, the MCRA team created a pre-determined change control plan (PCCP) to facilitate easy software updates without needing additional FDA submissions.
This plan is a notable accomplishment for MCRA and CamDiab, as it represents a new and complex concept from the FDA.
CamAPS FX is an advanced adaptive hybrid closed-loop app that acts as an 'interoperable automated glycaemic controller device' (iAGC). This Android app, recognized as the world's first artificial pancreas app, helps manage glucose levels in people with type 1 diabetes aged two and older, including during pregnancy.
It enables a compatible insulin pump and continuous glucose monitor to communicate, forming an artificial pancreas system.
"Team is excited to have supported CamDiab's innovative diabetes treatment app, CamAPS FX. Our Digital Health and Quality Assurance teams worked tirelessly to ensure the success of this groundbreaking app and are proud to have facilitated its FDA clearance."
"CamDiab deeply appreciates the invaluable support from MCRA's team in securing FDA clearance for our CamAPS FX app. The dedication and expertise of MCRA's Digital Health and Quality Assurance teams were crucial to our success."
"MCRA's experts lead the way in utilizing innovative approaches to achieve regulatory success for our clients. By exploring new submission pathways, our clients are better equipped to serve patients globally."
Source: prnewswire.com
