23 January 2020 | News
G Medical's Prizma device has been granted approval by the Taiwanese Food and Drug Administration.
Photo credit: G Medical Innovations
Mobile and e-health company G Medical Innovations based in the UK has received regulatory approval in Taiwan for its Prizma device, thereby extending its global market coverage and raising hopes of boosted sales in the near term.
On 20 Jan 2020, G Medical confirmed that Prizma was granted regulatory approval by the Taiwan Food and Drug Administration (FDA) with April cited as a likely licence issue date, although G Medical must still provide ancillary product information to the FDA before the company can commence sales.
With the licence insight, G Medical has announced that in partnership with First Channel, the company plans to “commence negotiations” with a view of securing a binding agreement for Prizma distribution across Taiwan, including cloud services, call centre operations and end-customer solutions.
“We will work collaboratively with First Channel to assist in the final steps towards receiving the permit licence,” said Dr Yacov Geva, chief executive officer of G Medical.
“The company will remain in discussions with First Channel regarding a commercial strategy for the region, as well as assess additional opportunities where applicable,” he said.
The company is expected to be venturing into China as a priority destination, having completed the necessary clinical trials required to obtain National Medical Products Administration (NMPA) approval for Prizma in China.
Last week, G Medical advised the market that it had completed more than 200 trials at three partner hospitals in China.
The Prizma device trials including measurements for electrocardiography, blood-oxygen saturation and body temperature using the Prizma device benchmarked against the relevant gold standard hospital diagnostic equipment, the company said.
Chinese approval, if granted, is widely expected to unlock market entry for G Medical and paves the way for Prizma to be distributed nationwide.
G Medical Devices
G Medical specialises in innovative next-generation mobile and e-health solutions using its own devices and software. The company has been operating since 2014 and is looking to develop multiple revenue streams across several regions simultaneously.
Currently, G Medical offers a suite of consumer and professional clinical-grade products, all of which have regulatory approval in various regions globally.
The fundamental theme throughout all the products it makes is the intention to streamline healthcare services with improved access, lower costs and better usability for patients.
The device now approved in Taiwan, Prizma, is a medical smartphone case that allows consumers to turn their smartphone into a mobile medical monitor to measure a wide range of vital signs and biometric parameters including medical cloud data storage and shareability.
G Medical also offers a professional real-time patient continuous monitoring solution, G Medical’s Vital Signs Monitoring System (VSMS) and G Medical Patch (GMP) – a modular solution measuring vital signs and automatically presented in a professional setting. The service assists in diagnosing patient complaints and conditions remotely and drastically improve preventative measures and response times.
Taiwanese approval news boosted G Medical shares by 42% up to $0.185.