Pic Solution One Rapid
Device Name:
One Rapid
Manufacturer:
Pikdare S.r.l., Via Saldarini Catelli 10, 22070 Casnate con Bernate, ITALY.
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
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Description:
The Pic Solution One Rapid 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 Pic Solution One Rapid, 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 to the Transtek TMB-2296-BT 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.
Transtek TMB-2296-BT
Xie Z, Zhu L, Zheng X, Li C, Hu J, Wang X, Deng H, Du X, Liang J, Peng B. Validation of the TMB-2296-BT blood pressure monitor in adults according to the ISO 81060-2:2018 + Amd.1:2020. Blood Press Monit. 2025 Jun 1;30(3):122-125. Epub: 2024 Oct 4. doi: 10.1097/MBP.0000000000000728. PMID: 39436236.
81060-2:2018/Amd 1:2020 - Pass General population