Nemaura, a Loughborough, England-based medical technology company received CE approval for its non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) SugarBEAT® for use by diabetics and pre-diabetics. This approval allows Nemaura to sell SugarBeat throughout the European Union.
“We are very pleased to report CE Mark approval in Europe for SugarBEAT®, which is the world’s first non-invasive, needle-free, continuous glucose monitor (CGM). Importantly, as a daily disposable adhesive skin-patch that sits on the surface of the skin, SugarBEAT® is painless and versatile in terms of wear time. Given these benefits, we look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets, said Dr. Faz Chowdhury, CEO of Nemaura.
“In addition, we plan to target the wearable health tech market for health-conscious consumers, which is experiencing explosive growth. Due to the non-invasive nature of the sensor patch and connection to a rechargeable transmitter, SugarBEAT® will allow users the freedom to decide when, and for how long to wear the patch. Moreover, we have a unique competitive advantage, which we believe will make SugarBEAT® the lowest priced CGM device in the industry. SugarBEAT® is protected by a solid IP portfolio with over 30 issued and pending patents across multiple patent families.”
Key features of SugarBeat
- Non-invasive, needle-free, disposable adhesive skin-patch connected to a rechargeable transmitter
- Lowest priced CGM in the industry
- Enables users to spend more time in range (TIR) by providing an ambulatory glucose profile (AGP) chart
Nemaura plans to submit an application for U.S. FDA approval in mid-2019, the company said in a news release.
Product launch in the United Kingdom and Germany is planned for next quarter.