Loughborough, England-based medical technology company Nemaura announced it is planning to launch a digital healthcare subscription service in the USA under the brand name proBEAT™.
proBEAT, which comprises a non-invasive glucose monitor and a digital healthcare subscription service, is expected to be available without the need for a prescription and appeal to a broad range of adults encompassing pre-diabetic and Type 2 diabetics.
Over 88 million American adults have prediabetes – that’s 1 in 3 adults. Of those 88 million, more than 8 in 10 of them don’t even know they have it. More than 34 million Americans have diabetes (about 1 in 10), and approximately 90-95% of them have type 2 diabetes.
The company is considering various options to expedite the launch of proBEAT in the US, including potential partnering with multi-national companies.
Nemaura hopes proBEAT will help users improve their knowledge of how a range of lifestyle, dietary and health and wellbeing factors impact their sugar levels by acting like a black box flight recorder. Big data about the multitude of factors that affect glucose levels will be gathered from all users and employed in developing and subsequently ‘fine-tuning’ predictive algorithms and artificial intelligence-based feedback and prompts. These will then be able to both educate and provide motivational tools to the user to encourage them to lead a healthier lifestyle, reports Business Wire.
Nemaura intends to market this device as a general wellness product as described in the FDA’s guidance document on the subject. General Wellness Products outlined in current FDA guidance are those which have either: (1) An intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or disease conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
Nemaura develops micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT™, and proBEAT™. sugarBEAT, a CE mark approved Class IIb medical device, is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse and prevent the onset of diabetes. Nemaura is planning to submit a PMA application for sugarBEAT during the second quarter of 2020 for FDA review of this device under medical device regulations.