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AViTA BPM64 (V2)
Device Model:
BPM64 (Note: 2 of 2)
Manufacturer:
AViTA Corporation, 9F No. 78 Sec 1, Gwang-Fu Road, Sanchong Dist., New Taipei City 24158, TAIWAN ROC.
Measuring functions:
Blood Pressure and PR
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 BPM64 (V2) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the AViTA BPM64 (V2) to measure blood pressure.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Not recommended This device has not been clinically validated.
Device Family:
AViTA BPM64 (V1)P, AViTA BPM64 (V2)P, AViTA BPM68P, AViTA BPM82P, AViTA BPM83P, AViTA BPM925-LJBP, Novama Comfort+ AF (BP 68)P, Novama First+ (V2)P, Novama Prime (BPM83)Z, Novama Prime+ (BPM83)P, Novama Pro BlueP, Novama White M (BPM82)Z, Novama White M+ (BPM82)Z, Novama BP
Legend: P Stride Equivalence, Z Almost Certain
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 BPM64 (V1)

Kang YY, Chen Q, Liu CY, Li Y, Wang JG. Validation of the AVITA BPM64 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2018 Feb;23(1):45-8. Epub: 2017 Oct 18. doi: 10.1097/MBP.0000000000000296. PMID: 29049094.

ESH-IP:2010 - Pass General population

AViTA BPM82

Menti A, Ntousopoulos V, Theodosiadi A, Stathopoulou P, Kollias A, Stergiou GS. Validation of the automated oscillometric upper-arm cuff home blood pressure monitor AVITA BPM82 in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Blood Press Monit. 2024 Apr 1;29(2):89-92. Epub: 2023 Nov 6. doi: 10.1097/MBP.0000000000000682. PMID: 37937605.

81060-2:2018/Amd 1:2020 - Pass General population

Menti A, Lempidaki P, Mariglis D, Antonogiannaki EC, Bakalakou KR, Komnianou A, Kollias A, Stergiou GS. Validation of the automated oscillometric home blood pressure monitor AViTA BPM82 in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Blood Press Monit. Epub: 2026 Feb 2. doi: 10.1097/MBP.0000000000000795. PMID: 41670419.

81060-2:2018/Amd 1:2020/Amd 2:2024 - Pass General population

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