Mobile and e-Health company G Medical Innovations has announced US FDA 510(K) Class II approval to market and sell its Prizma Medical Smartphone Jacket.
The Prizma is one of two products developed by G Medical. It allows consumers to turn their smartphone into a mobile medical monitor to measure a wide range of vital signs. Users can store their medical data in the cloud and share it with any third party, including healthcare professionals and family.
According to the company, similar regulatory approvals are in progress in China, Europe, Australia and other markets.
“Today marks a very significant milestone in the history of G Medical as we receive clearance from the FDA to launch into the United States," said CEO Dr Yacov Geva.
"Such news is in line with our commitment to shareholders to move quickly from development to commercialisation. It also aligns with our vision as we continue to develop our product pipeline based on our strong IP portfolio. Availability of the Prizma in the near future will immediately benefit consumers and their healthcare providers.”