Nanowear’s SimpleSense-BP Cleared for Blood Pressure Monitoring and Hypertension Diagnostics

January 4, 2024—Nanowear announced that its wearable SimpleSense software platform has received a new FDA 510(k) clearance for the nanotechnology- and artificial intelligence- (AI-) enabled Software-as-a-Medical Device (SaMD). The SimpleSense-BP is a noninvasive, cuffless, continuous blood pressure (BP) monitor and diagnostic tool for the management of hypertension. The SaMD clearance of SimpleSense for BP adds to the wearable platform’s previous clearance for cardiopulmonary diagnostics.

Nanowear advised that the SimpleSense platform is indicated for use at home, in health care facilities, and in clinical research. This is the company’s fourth FDA clearance for its nanotechnology technology.

According to the company, the SimpleSense-BP’s four-decision tree algorithmic model was tested in three study arms. Both training and validation were performed in independent geographies and demographic populations mirroring the most recent United States census and generalizability to the entire hypertensive population.

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

In the Nanowear press release, Ken Ouriel, MD, Chief Medical Officer of NAMSA, the cardiovascular medtech clinical research organization, discussed the SimpleSense technology.

“We often talk about whitecoat syndrome limiting our ability to understand the effect of therapeutics in blood pressure or other cardiopulmonary assessments,” commented Dr. Ouriel. “Whitecoat syndrome is just another word for ‘real-world’ living. Just as a patient’s blood pressure may be high in a 3-second reading due to whitecoat syndrome, the same patient may reduce their blood pressure by breathing calmly for 5 minutes before the 30-second reading. So, what are we actually learning about that individual patient or the therapeutic applied? To date, existing health care wearables and software platforms are either restricted in scope and time; or are unreliable and unvalidated for what they can diagnose during ‘real-world’ conditions.”

Dr. Ouriel continued, “Nanowear’s continuous device, software platform, and AI algorithms, can transform the way clinical research platforms operate. Efficiency, access, diversity, and standardization across geographies can be enhanced while significantly lowering trial costs. Importantly, sponsors would be able to receive clinically reliable and trended data-driven insights; data from the real world; their patients’ homes, their workplace, and a myriad of other settings that comprise everyday life.”