SimpleSense is an FDA cleared remote diagnostic platform. The cloth-based nanosensor technology undergarment monitors multiple patient vitals such as heart rate, blood pressure, respiration rate, and physical activity.
October 4, 2021 – Nanowear, a hospital-at-home and remote diagnostic platform that used proprietary wearable cloth nanotechnology sensors and artificial intelligence (AI), received its third FDA 510(k) clearance and first software-only clearance as an end-to-end digital platform. This clearance enables Nanowear to implement standalone AI and deep learning algorithms that will inform remote diagnoses as software-as-a-medical sevice (SaMD).
The company is also working on FDA clearances for its software to diagnose or monitor hypertension, COPD, sleep apnea, worsening heart failure and post-surgical recovery.
Nanowear’s SimpleSense uses its proprietary cloth-based, wearable smart nanosensor technology to capture and analyze these low-noise, and 85 hospital-grade biomarkers using time-synchronous scattering methods.
“AI has the invaluable ability to assist healthcare providers and payers in tracking complex biological systems and individual risk patterns within the human body where the data is inherently high-dimensional,” said Peter Norvig, director of research at Google and co-author of a popular university textbook in artificial intelligence, "Artificial Intelligence: A Modern Approach. “When time-synchronously tracking a complex system like a patient’s heart, lungs and upper vascular system, the data captured needs to match the system’s level of complexity. Nanowear’s 85+ biomarkers of high-fidelity data within a closed loop system enables unique AI and deep learning algorithms to ensure that need is met.”
“The largest bottleneck for any AI deployment is data preparation, which can take 70% - 80% of the time in any given application,” said Venk Varadan, co-founder and CEO of Nanowear. “Unlike wrist or armband device-enabled hospital-at-home platforms that do not yield high-fidelity longitudinal data, our SimpleSense platform utilizes clinical-grade biomarkers with a high SNR (signal-to-noise) ratio. The time required to see results with our neural network is significantly shorter, meaning we have the profound ability to scale the capabilities of our platform immediately. SimpleSense truly does get smarter with each patient.”
This FDA 510(k) clearance establishes Nanowear’s core data assets, secures existing data architecture, and unifies the digital platform through guiding principles like security, privacy, modularity, scalability, interoperability and utility. This unified digital platform integrates hospital-grade nanosensors, telehealth software and AI-driven decision support to radically transform virtual care and enable providers to triage risk profiles of the cardio, pulmonary and upper vascular systems of patients while they are in the comfort of their own home.
For more information: www.nanowearinc.com
May 13, 2026 
