The US Food and Drug Administration has granted FDA 510(k) clearance to Nanowear’s SimpleSense, an artificial intelligence-enabled non-invasive, cuffless continuous blood pressure monitor and diagnostic. 

The platform enables physicians to offer patients full routine cardiopulmonary examinations at home, in healthcare facilities, and in clinical research.

The four-decision tree algorithmic model, SimpleSense-BP, was tested in three study arms with both training and validation performed in independent geographies and demographic populations mirroring the most recent US census and generalizability to the entire hypertensive population. 

SimpleSense-BP is validated to track changes of > +/- 15mmHg systolic and +/- 10mmHg diastolic blood pressures over a continuous recording period across all classes of hypertension, via its wearable undergarment and AI platform.

Nanowear, winner of the 2023 Innovation Pitch Challenge by The American College of Cardiology (ACC), organized in partnership with the National Heart, Lung, and Blood Institute, was one of five companies selected for the 2023 HeartX cohort, powered by MedAxiom (an ACC company) and Healthtech Arkansas. 

Joe Sasson, PhD, MedAxiom’s chief commercial officer and executive vice president of Ventures, says in a release, “SimpleSense-BP’s continuous AI algorithm uses software quality management to mitigate against human error and other complexities of hypertension management, and it incorporates known confounders such as age, height, weight, ethnicity, and breathing rate as algorithmic inputs.”

He adds in a release, “With more than 100 real-world examples in validation, this AI and home-based digital health platform offers collaborative intelligence to cardiologists, clinical researchers, and the empowered consumer, ultimately improving care pathways for this critical disease state. Additionally, the technology allows cardiovascular programs to achieve an increased frequency of data collection while using fewer staff and providing an improved patient experience, which are meaningful benefits for all cardiovascular organizations today.”

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