Nanowear announced that its nanotechnology-enabled wearable and software platform, SimpleSense, has received U.S. FDA 510(K) clearance for a AI-enabled Software-as-a-Medical Device (SaMD).

As a non-invasive, cuffless, continuous blood pressure monitor, and diagnostic, SimpleSense-BP provides a transformational tool in clinical diagnostic management of hypertension and is additive to the wearable platform’s previously cleared cardiopulmonary diagnostics.

“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, utilizing AI, and a proven team that executes,” said Venk Varadan, CEO and co-founder of Nanowear. “This SaMD is just the first example of what our nanotechnology and AI is capable of, in understanding the individualized risk signatures and cardiopulmonary care pathways of each patient, materially enabling precision medicine.”

With its fourth FDA 510(k) clearance, alongside 13 awarded and 12 pending patents covering its nanotechnology, Nanowear’s SimpleSense is uniquely positioned in the market: the platform is indicated for use at-home, in healthcare facilities, and clinical research. The novel 4-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.