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Nanowear's SimpleSense-BP Receives FDA Clearance for AI-Enhanced Blood Pressure Monitoring

Friday, January 05, 2024

Nanowear, a prominent player in remote healthcare diagnostics, has unveiled the FDA 510(k) clearance for its cutting-edge SimpleSenseTM platform. This innovative platform features an AI-enabled Software-as-a-Medical Device (SaMD), particularly in its novel offering, SimpleSense-BP, the first cuffless continuous blood pressure monitor. This device significantly enhances the clinical diagnostic management of hypertension and complements the existing cleared cardiopulmonary diagnostics within the platform.

This regulatory milestone marks a noteworthy achievement for Nanowear, addressing the rising market demand for reliable, at-home wearable solutions driven by AI. The unique 4-decision tree algorithmic model embedded in SimpleSense-BP underwent thorough testing, ensuring its accuracy across diverse demographics. The continuous AI algorithm is designed to improve hypertension management by incorporating various inputs such as age, height, weight, ethnicity, and breathing rate.

According to Sasson, the platform's continuous AI algorithm utilizes software quality management to mitigate human errors and other complexities associated with hypertension management. With validation involving over 100 real-world examples, this home-based digital health platform not only provides collaborative intelligence for healthcare professionals and researchers but also empowers consumers in managing critical health conditions.

Furthermore, this technology offers tangible benefits to cardiovascular programs by enabling increased data collection frequency with fewer staff requirements, ultimately enhancing the overall patient experience. Nanowear's FDA clearance signifies a pivotal step forward in delivering advanced healthcare solutions tailored to the evolving needs of the industry.


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