A groundbreaking wearable technology has received FDA clearance for its artificial intelligence-powered software that enables continuous monitoring of blood pressure without the need for an inflatable cuff. The SimpleSense wearable, created by Nanowear, is a chest-mounted garment that utilizes cloth-based sensor technology to provide medical-grade remote vital sign tracking, including ECG data and heart sounds.
The FDA’s approval of the SimpleSense-BP program marks Nanowear’s fourth green light and aims to support the at-home diagnosis of hypertension and its use within healthcare facilities and clinical studies. The device’s ability to gather readings in everyday settings may provide more accurate results compared to readings taken in a physician’s office, where anxiety can artificially raise blood pressure levels. In contrast, controlled breathing techniques can help lower blood pressure readings.
While initially designed for blood pressure monitoring, the SimpleSense garment is also being developed to track other conditions such as COPD and sleep apnea. Nanowear’s co-founder and CEO, Venk Varadan, highlights the significance of the FDA clearance for the company, stating that the market has been eagerly searching for reliable wearable solutions that combine AI technology with clinical-grade accuracy.
The SimpleSense-BP program has undergone rigorous validation and has been shown to log changes of more than 15 mmHg systolic and 10 mmHg diastolic blood pressures over a continuous recording period. This level of accuracy makes it a promising tool for diagnosing and managing hypertension.
Nanowear’s SimpleSense garment initially received FDA clearance in November 2020 and has since expanded its capabilities through software updates. The company is actively working on further clearances to track conditions such as COPD, sleep apnea, and post-surgery recovery.
Overall, the approval of this AI-powered wearable technology represents a significant milestone in the field of remote healthcare monitoring, offering the potential for more accessible and accurate blood pressure management for individuals in the comfort of their own homes.
The source of the article is from the blog jomfruland.net