Nova Max Link
Device Name:
Max Link
Manufacturer:
Nova Biomedical Corporation, 200 Prospect St, Waltham, MA 02454-9141, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Description:
The Nova Max Link is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Nova Max Link, to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BG | Institute of Health Economics (CA) | General use | No evidence provided |
Relevant Publications:
Greene C, Brown D, Wallace JF, Pardo S, Pflug B. Comparative Accuracy of 3 Blood Glucose Monitoring Systems that Communicate with an Insulin Pump. Endocr Pract. 2014 Oct;20(10):1016-21. doi: 10.4158/EP13484.OR. PMID: 24793918.
Measurements from the Nova Max Link are compared to those from the Ascensia (Bayer) Contour Next Link and the J&J OneTouch UltraLink, though not in a formal validation.