TL;DR:
- Nanowear obtains FDA clearance for AI-powered blood pressure monitoring software.
- SimpleSense wearable utilizes cloth-based sensors for medical-grade vital sign tracking.
- The clearance aims to support at-home hypertension diagnosis and clinical studies.
- Nanowear’s innovative technology offers more accurate readings in everyday settings.
- CEO Venk Varadan highlights the significance of the FDA approval.
- SimpleSense-BP system can detect significant blood pressure changes over continuous monitoring.
- Nanowear previously gained FDA clearance for its digital stethoscope garment in 2020.
- The company’s software-only solution received FDA approval in September 2021.
- Nanowear plans to expand its machine learning techniques for tracking COPD, sleep apnea, and post-surgery recovery.
Main AI News:
Nanowear, the innovative smart clothing manufacturer, has achieved a significant milestone with its latest FDA clearance. The company’s cutting-edge wearable technology, known as SimpleSense, has been granted FDA approval for its AI-powered software that allows continuous blood pressure monitoring, eliminating the need for traditional inflatable cuffs.
Designed to fit snugly across the wearer’s chest, Nanowear’s SimpleSense wearable utilizes cloth-based sensor technology to deliver medical-grade remote vital sign monitoring, including ECG data and heart sounds. This breakthrough 510(k) clearance marks the fourth successful approval for the company and specifically focuses on the SimpleSense-BP program.
The primary objective of the SimpleSense-BP program is to facilitate the diagnosis of hypertension in the comfort of one’s home, as well as in healthcare facilities and clinical studies. Unlike traditional blood pressure measurements taken in clinical settings, everyday environments provide more accurate readings, as they mitigate the influence of anxiety on blood pressure levels, while controlled breathing can yield more precise results.
Venk Varadan, co-founder and CEO of Nanowear, expressed his enthusiasm, stating, “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 wearables and data service solutions that possess three key attributes: at-home usability, AI integration, and a proven team for execution.”
According to Nanowear, the SimpleSense-BP system has undergone extensive validation and can record changes of more than 15 mmHg in systolic and 10 mmHg in diastolic blood pressure over a continuous monitoring period.
Nanowear initially gained FDA clearance for the SimpleSense garment in November 2020. This innovative wearable combined the functionalities of a digital stethoscope, Holter heart monitor, and capnograph respiratory tracker. It played a vital role in clinical trials, assisting in the diagnosis of conditions such as worsening heart failure and COVID-19.
In September 2021, the company received FDA approval for its software-only solution, introducing an end-to-end digital platform for patient monitoring. Nanowear’s future plans involve leveraging machine learning techniques to secure additional clearances for tracking conditions such as COPD, sleep apnea, and post-surgery recovery.
Conclusion:
Nanowear’s FDA clearance for AI-enhanced blood pressure monitoring signifies a significant step in the wearable technology and healthcare market. This approval positions Nanowear as a key player in delivering reliable, clinical-grade wearables with AI integration, meeting the growing demand for at-home healthcare solutions. The company’s commitment to innovation and further clearances for various medical conditions is set to have a substantial impact on the market.
