MedApp SA, a Polish digital health company specializing in big data analytics, artificial intelligence and mixed reality, has chosen Parexel Biotech as an advisor for the registration process in the U.S. Food and Drug Administration (FDA). Parexel Biotech is a division of Parexel International, a global leader in biopharmaceutical and CRO (contract research organization) services, that provides tailored services to help biotech and medical device companies meet their development goals.
MedApp’sCarnaLife technology is already approved in Europe as a Class IIB medical device. This allows MedApp to offer its key software solutions - CarnaLifeHolo, an application for holographic visualization of diagnostic data imaging and the CarnaLifeSystem, a telemedicine platform - in Poland, EU, the Middle East, Africa and selected Asian countries. Now MedApp is seeking to enter the North American market.
“United States domestic market is a promising market for MedApp. It is by far the largest market in the world for medical innovation. After obtaining European registration and starting commercialization in Europe, United States becomes a natural market for further expansion for our products,“ says Krzysztof Mędrala, CEO of MedApp S.A.
“Parexel Biotech is excited to support MedApp on this important medical device registration to the US FDA. Leveraging Parexel’s 1000+ Regulatory staff worldwide, we support biotech, medical device, and technology companies with their Regulatory and Access needs, bringing both subject matter expertise and operational experience with global agencies,” says Jim Anthony, SVP of Parexel Biotech.