Nanowear has received 510(k) clearance from the US Food and Drug Administration (FDA) for its SimpleSense-BP, an AI-enabled software-as-a-medical device (SaMD), for continuous blood pressure monitoring.
SimpleSense-BP is claimed to be the first non-invasive, cuffless, continuous blood pressure monitor and diagnostic tool. It is designed to transform the clinical management of hypertension.
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.”
The company’s fourth FDA 510(k) clearance complements its intellectual property portfolio, which includes 13 awarded and 12 pending patents.
The four-decision tree algorithmic model, SimpleSense-BP, has undergone rigorous testing across three study arms.
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Training and validation were carried out in diverse geographic and demographic populations, reflecting the latest US census data to ensure broad applicability to the hypertensive population.
The system has been validated to track systolic and diastolic blood pressure changes over a continuous recording period, catering to all hypertension classes through its wearable undergarment and AI platform.
Nanowear said its SimpleSense is approved for use in various settings, from home care to healthcare facilities and clinical research.
The digital platform is a wearable device that can capture and analyse more than 85 biomarker data points across the lungs, heart, haemodynamic, and central vascular system.