Nanowear has secured the US Food and Drug Administration (FDA) 510(k) clearance for SimpleSense-BP, an artificial intelligence (AI)-enabled continuous blood pressure monitoring and hypertension diagnostic management platform.
SimpleSense-BP is said to be the first non-invasive, cuffless, continuous blood pressure monitor and wearable diagnostic platform.
The FDA has approved the platform as Software-as-a-Medical Device (SaMD).
According to Nanowear, the tool supports clinical diagnostic management of hypertension and is additive to the wearable platform’s previously cleared cardiopulmonary diagnostics.
SimpleSense uses patented nanosensors fuelling transformative AI to allow physicians to offer patients secure and accurate routine cardiopulmonary examinations at home, in healthcare facilities, and in clinical trials.
The platform, a four-decision tree algorithmic model, is designed to capture and analyses 85+ unique biomarker data points across the heart, lungs, haemodynamic, and central vascular system.
SimpleSense is said to aggregate millisecond-by-millisecond cardiopulmonary examinations and provides high-quality, continuous, and time-synchronous biometric data for remote patient management.
Nanowear CEO and co-founder Venk Varadan said: “This FDA clearance represents an exciting and differentiating moment for Nanowear.
“Accelerated by the pandemic, the market has been eagerly searching for reliable, clinical-grade wearable, and data service solutions that find product market fit with the following three attributes: at-home, utilising AI, and a proven team that executes.
“This SaMD is just the first example of what our nanotechnology and AI is capable of, in understanding the individualised risk signatures and cardiopulmonary care pathways of each patient, materially enabling precision medicine.”
This represents the fourth FDA 510(k) clearance for the company along with 13 awarded and 12 pending patents for its technologies, software platforms, pipeline, and AI algorithms.
Nanowear said that SimpleSense-BP was assessed in three study arms with both training and validation conducted in demographic populations and independent geographies.
In November 2020, the firm secured FDA clearance for its SimpleSENSE cloth-based diagnostic platform.
