The BodyTrace BT-106 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.

There appears to be no peer-reviewed clinical validation information available on the technology used in the BodyTrace BT-106 to measure blood pressure. However, this device appears to be very similar to another device by the same (OEM) manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has not been shown to have been clinically validated.
BP	AMA VDL (US)	Self-measurement	Equivalence claim without published evidence