First Wearable Platform Allows Physicians to Offer Patients Full Routine Cardiopulmonary Examinations

Until now, the healthcare wearables and software platforms available have been limited in their scope and duration, or they have been unreliable and unverified for diagnosing conditions under real-world conditions. Now, a groundbreaking wearable platform employing patented nanosensors and sophisticated AI can empower physicians to conduct comprehensive routine cardiopulmonary examinations for patients at home, in healthcare facilities, and during clinical research.

Nanowear’s (New York, NY, USA; www.nanowearinc.com) SimpleSense is an AI-driven digital platform paired with a wearable device that captures and analyzes over 85 unique biomarker data points from the heart, lungs, hemodynamics, and central vascular system. This platform delivers high-quality, continuous, and synchronized biometric data, compiling cardiopulmonary assessments millisecond by millisecond to aid medical professionals in managing patients remotely. Leveraging proprietary nanosensors and sophisticated algorithms, SimpleSense is the world’s first comprehensive wearable platform, effectively supplanting primary diagnostic tools like the blood pressure cuff, digital stethoscope, multi-channel ECG, hemodynamic monitor, pulse oximeter, spirometer, and actigraphy monitors.

SimpleSense has obtained FDA 510(k) clearance as a novel AI-driven Software-as-a-Medical Device (SaMD). With its fourth FDA 510(k) clearance, alongside 13 granted and 12 pending patents that cover its nanotechnology, scalable nanosensor manufacturing, multi-parametric wearable, software platform, data ingestion pipeline, and AI algorithms in a fully integrated ecosystem, Nanowear’s SimpleSense is uniquely positioned in the market. It is indicated for use in various settings, from at-home and healthcare facilities to clinical research. The innovative 4-decision tree algorithmic model, SimpleSense-BP, underwent testing across three study arms with both training and validation conducted in diverse geographies and demographic populations, reflecting the most recent US census and providing a broad application to the entire hypertensive population. SimpleSense-BP is validated to monitor changes of > +/- 15mmHg systolic and +/- 10mmHg diastolic blood pressures over a continuous recording period for all classes of hypertension, using its wearable undergarment and AI platform.

“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, emphasizing the company’s distinction as the world’s only nanotechnology-based embedded sensor platform fueling irreproducible AI algorithms. “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.”

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