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Although both agree that validated, cuffed devices should be used for BP measurements, the ESH guidelines explicitly recommend against use of cuffless measurement devices. The ESH guidelines point to ...

Existing cuffless BP estimation techniques face limitations such as limited feature extraction capabilities, which can result in lower performance, and validation on nonstandard or small datasets, ...

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Yet, in many cases, the answer is much more complex. There is no single reason why an FDA-cleared OTC cuffless blood pressure measurement solution is unavailable in the marketplace today.

Background: Novel smartwatch-based cuffless blood pressure (BP) measuring devices are coming to market and receive FDA and CE labels. These devices are often insufficiently validated for clinical use.