Avita BPM65
Device Model:
BPM65
Manufacturer:
AViTA Corporation, 9F No. 78 Sec 1, Gwang-Fu Road, Sanchong Dist., New Taipei City 24158, TAIWAN ROC.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Avita BPM65 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Avita BPM65, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Stride BP | Self-measurement for adults (Preferred) | Equivalence claim without published evidence |
Device Family:
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Avita BPM63S
Kang YY, Zeng WF, Liu M, Li Y, Wang JG. Validation of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):46-9. doi: 10.1097/MBP.0000000000000014. PMID: 24322871.
ESH-IP:2010 - Pass General population