News | Cardiac Diagnostics | October 04, 2021

FDA Clears Nanowear Platform to Implement AI-based Home Diagnostics and Monitoring Network

System uses a wearable cloth-based nanosensor technology to monitor patients for worsening heart failure, post-surgical care and hypertension

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.

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

Find more wearable cardiac monitoring technologies


Related Content

News | Heart Failure

October 6, 2022 — The complications experienced by heart failure patients implanted with a left ventricular assist ...

Home October 06, 2022
Home
News | Heart Failure

October 6, 2022 — Findings from a Cleveland Clinic-led trial show that increasing the salt intake by mouth for patients ...

Home October 06, 2022
Home
News | Heart Failure

October 5, 2022 — The American Society of Echocardiography (ASE) is targeting its research funding over the next five ...

Home October 05, 2022
Home
News | Heart Failure

October 5, 2022 — New data presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2022, held ...

Home October 05, 2022
Home
News | Heart Failure

October 4, 2022 — Newswise — Daxor Corporation, a global leader in blood volume measurement technology, today announces ...

Home October 04, 2022
Home
News | Heart Failure

October 3, 2022 — scPharmaceuticals Inc., a pharmaceutical company focused on developing and commercializing products ...

Home October 03, 2022
Home
News | Heart Failure

September 29, 2022 — Bloodstream levels of a protein fragment called endotrophin can be used to predict outcomes in ...

Home September 29, 2022
Home
News | Heart Failure

September 28, 2022 — A University of Massachusetts Amherst nurse engineer is leading a team of researchers who are ...

Home September 28, 2022
Home
News | Heart Failure

September 19, 2022 — A first-in-human (FIH) study using the ModulHeart device (Puzzle Medical Devices Inc.) has ...

Home September 19, 2022
Home
News | Heart Failure

September 15, 2022 — Today, aortic stenosis (AS) is one of the most common and serious valve disease problems [1]. It ...

Home September 15, 2022
Home
Subscribe Now