Nemaura Medical files premarket application for sugarBEAT glucose monitor with FDA
Nemaura Medical Inc (NASDAQ:NMRD) announced Tuesday that it has submitted a Premarket Approval (PMA) application to the US Food and Drug Administration for its sugarBEAT continuous glucose monitor.
sugarBEAT is designed to help people with diabetes monitor and track their glucose profiles as a supplement to finger prick testing. In the case of Type 2 diabetic population, which the company says is its initial target, sugarBEAT can help manage or potentially reverse diabetes by keeping users better informed about their glucose profiles
“The USA represents the largest single market for sugarBEAT and submission of the PMA application is a major milestone for the company,” CEO Faz Chowdhury said in a statement.
READ: Nemaura Medical “to take full advantage” to commercialize sugarBEAT continuous glucose monitor in US
“Whilst the PMA application is under review for approval of sugarBEAT as a Class III medical device, we plan to launch proBEAT in the USA later this year,” Chowdhury added. “proBEAT will be introduced as a wellbeing device whereby we will be collecting glucose profiles and developing artificial intelligence-based prompts and feedback on how different factors affect glucose levels to help people make informed lifestyle choices”.
The company expects proBEAT to be available without the need for a prescription and appeal to a broad range of adults encompassing pre-diabetic and Type 2 diabetics — 88 million and 26 million people, respectively — as well as those seeking to lose weight and have a healthier lifestyle.
Nemaura also announced that Chowdhury will participate in an investor webinar hosted by RedChip Companies at 11 am ET on Tuesday.
The CEO will provide an update on the UK-based company’s developments, including commercialization progress, US product launch and collaborative partnerships, as well as offer an update on a continuous temperature monitor for both the diabetes and non-diabetes markets. A Q&A will follow the presentation.
Contact Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/923648/nemaura-medical-files-premarket-application-for-sugarbeat-glucose-monitor-with-fda-923648.html
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