Nanowear SimpleSense-BP

Description:

The Nanowear SimpleSense-BP is an ai algorithm for measuring blood pressure. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood pressure measurements are taken from the torso. It is intended for self-measurement and home use.

Assessment:

The technology used in the Nanowear SimpleSense-BP, to measure blood pressure, has been assessed, in a general population, according to a non-standard protocol.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications:

Lopez-Jimenez F, Deshmukh A, Bisognano J, Boehmer J, Ramasamy M, Shyam Kumar P, Kapa S, Varadan V, Varadan V, Fudim M. Development and Internal Validation of an AI-Enabled Cuff-less, Non-invasive Continuous Blood Pressure Monitor Across All Classes of Hypertension. J Cardiovasc Transl Res. 2025 Apr;18(2):280-290. Epub: 2025 Jan 13. doi: 10.1007/s12265-024-10589-5. PMID: 39804564.

Ad Hoc protocol General population

Relevant Publications:

Rai P, Oh S, Shyamkumar P, Ramasamy M, Harbaugh RE, Varadan VK. Nano- Bio- Textile Sensors with Mobile Wireless Platform for Wearable Health Monitoring of Neurological and Cardiovascular Disorders. J Electrochem Soc. 2013 Dec 31;161(2):B3116-B3150. doi: 10.1149/2.012402jes. Available from: iopscience.iop.org.

Kumar PS, Rai P, Ramasamy M, Varadan VK, Varadan VK. Multiparametric cloth-based wearable, SimpleSense, estimates blood pressure. Sci Rep. 2022 Jul 29;12:13059 . doi: 10.1038/s41598-022-17223-x. Available from: www.nature.com.