WASHINGTON, June 26, 2024/PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in aiding CamDiab’s artificial pancreas software, CamAPS FX, in achieving U.S. Food and Drug Administration (FDA) clearance.
CamDiab retained MCRA’s team of Digital Health and Quality Assurance experts to assist with the FDA submission process for the CamAPS FX app. Due to the nature of the software used, the MCRA team assembled a pre-determined change control plan (PCCP) to ensure the software could be updated easily, without the need for additional FDA submissions. The pre-determined change control plan is an impressive achievement for MCRA and CamDiab, as it is a relatively new concept from the FDA with a high-level of expertise needed.
The CamAPS FX is an advanced adaptive hybrid closed-loop app that acts as an ‘interoperable automated glycaemic controller device’ (iAGC). The Android app – known as the world’s first artificial pancreas app – helps to manage glucose levels in people with type 1 diabetes, aged two and older, including during pregnancy. The app allows a compatible insulin pump and a compatible continuous glucose monitor to ‘talk to each other’, creating an artificial pancreas.
Nima Akhlaghi, Director, Digital Health & Imaging Center Lead at MCRA states, “MCRA’s team is thrilled to have helped support CamDiab’s new app for diabetes treatment, CamAPS FX. Our Digital Health and Quality Assurance teams worked diligently to provide an avenue to success for this innovative diabetes app and are proud to have assisted in obtaining FDA clearance.”
Dr. Roman Hovorka at CamDiab said, “CamDiab is grateful for the invaluable support provided by MCRA’s team in achieving FDA clearance for our innovative diabetes treatment app, CamAPS FX. The dedication and expertise of MCRA’s Digital Health and Quality Assurance teams were instrumental in our success, and we appreciate their tireless efforts in paving the way for this milestone.”
Anthony Viscogliosi, CEO of MCRA states, “MCRA’s experts lead the industry in utilizing new and innovative approaches to secure regulatory success for our clients. By exploring these new pathways for submissions, our clients are better able to serve patients around the world.”
About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client’s industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
About CamDiab: CamDiab Ltd is a digital health and personalized medicine company focused on the design, development, and commercialisation of its world leading, interoperable CamAPS FX closed loop app. The CamAPS FX is designed to use adaptive, self-learning control algorithm, linked to a compatible continuous glucose monitoring device and a compatible insulin pump, to autonomously compute and direct insulin delivery to maintain desired glycaemic levels. Since its founding in 2019, its mission has been to help people with type 1 diabetes and their families live better lives. For further information, visit www.camdiab.com or follow CamDiab Ltd and its products on Facebook, LinkedIn, and X (formerly Twitter) @CamAPS_FX.
For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com