Bionime Rightest GM300
The technology used in the Bionime Rightest GM300, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations | ||
| TÜV Rheinland Nederland | General use | Unpublished internal data | ||
| Institute of Health Economics (CA) | General use | No evidence provided | ||
| MDR Criteria | Self-measurement and professional use | Published evidence | ||
Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.
15197:2003 - Pass General population
Yu-Fei W, Wei-Ping J, Ming-Hsun W, Miao-O C, Ming-Chang H, Chi-Pin W, Ming-Shih L. Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study. J Diabetes Sci Technol. 2017 Sep;11(5):953-65. Epub: 2017 May 8. doi: 10.1177/1932296817705143. PMID: 28480733. Available from: PMC5950995.
15197:2013 - Pass General population
15197:2003 - Pass General population
