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Nemaura Medical wins regulatory approval for non-invasive glucose sensor in the Middle East

August 17, 2023 By Sean Whooley

Nemaura Medical sugarBEAT continuous glucose monitor CGM
The sugarBEAT CGM. [Image from Nemaura Medical]
Nemaura Medical (Nasdaq:NMRD) announced today that it received Saudi Food and Drug Authority (SFDA) approval for its sugarBEAT sensor.

The company develops daily, non-invasive, disposable, wearable glucose sensors. It also offers digital diabetes management tools and earlier this year added CGM-guided insulin dose titration to its offerings.

Nemaura’s sugarBEAT, a CE-marked device, offers non-invasive, flexible continuous glucose monitoring (CGM). It provides actionable insights derived from real-time glucose measurements and daily glucose trend data. It could help people with diabetes and pre-diabetes better manage, reverse and prevent the onset of the chronic condition.

Loughborough, England-based Nemaura submitted an FDA premarket approval application for sugarBEAT in the U.S. The company also said it filed an application for the reimbursement of sugarBEAT in the UK recently.

According to the company, approval in Saudi Arabia follows a year of liaisons with the SFDA. The company said it represents a “major breakthrough” for commercialization in the Middle East’s regions largest territory. A 2021 report said nearly 4.5 million people (18.3% of the adult population) in Suadi Arabia have diabetes, Nemaura said. That compares to a 9.3% global average.

Nemaura previously announced the receipt of a provisional purchase order for 1.7 million sensors and 17,000 devices from its TPMENA Middle East licensee. The company now plans to work with TPMENA to fulfill the purchase order.

“The Company believes that SFDA approval places Nemaura Medical in an unparalleled position to gain approval across the Gulf and other regions, and to commercialize its digital programs,” Nemaura said in a news release.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Nemaura Medical

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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