Visgeneer eBsensor (eB-G)

Device Name:

eBsensor

Device Model:

eB-G

Manufacturer:

Visgeneer Inc., No. 335 Sec. 6, Zhonghua Rd., Xiangshan Dist., Hsinchu City 30094, TAIWAN ROC.

Measuring functions:

Blood glucose, β-Ketones

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Visgeneer eBsensor (eB-G) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Visgeneer eBsensor (eB-G), to measure blood glucose, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has failed a clinical validation.
BG	Institute of Health Economics (CA)	General use	No evidence provided

Validation Publications:

Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.

15197:2013 - Fail General population (Note: Modified protocol: One reagent system lot.)

Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.

15197:2013 - Fail General population