Remote diagnostics company Nanowear has achieved a significant milestone with the FDA granting 510(k) clearance for its revolutionary nanotechnology-enabled wearable, SimpleSense-BP, designed to function as a continuous blood pressure monitor. This Softwear-as-a-Medical Device (SaMD) platform combines proprietary cloth-embedded nanotechnology sensors with artificial intelligence (AI) and machine learning (ML), offering clinical-grade decision support in the realm of cardiopulmonary health.
The FDA clearance marks a pivotal moment for the company, emphasizing the demand for reliable and AI-utilizing wearable solutions, particularly those fitting the criteria of at-home use. Venk Varadan, CEO and co-founder of Nanowear, expresses enthusiasm, stating “This SaMD is just the first example of what our nanotechnology and AI is capable of, in understanding the individualized risk signatures and cardiopulmonary care pathways of each patient, materially enabling precision medicine.”
Nanowear, established in 2014, holds more than a dozen patents, primarily focusing on cloth embedded with nano-sensors for continuous monitoring of patients' cardiopulmonary health. SimpleSense-BP employs a gender-neutral sash worn as an undergarment, embedding nano-sensors capable of monitoring 85 distinct biomarkers related to cardiopulmonary function. These biomarkers generate vast data points, exceeding 100 million per day through
continuous monitoring. The data is then processed by a closed-loop AI- and ML-enabled platform, providing healthcare providers with actionable information remotely.
The integrity of data from nano-sensors is a cornerstone for Nanowear's diagnostic algorithms, ensuring fast and accurate analysis. Unlike conventional wrist or armband devices, SimpleSense stands out by utilizing clinical-grade biomarkers with a high signal-to-noise ratio, reducing the time required for AI neural network analysis.
The company's SimpleSense platform has already demonstrated a substantial reduction in provider workflow and patient time, approximately by 60%. Furthermore, it possesses the capability to evolve and improve its diagnostic accuracy with each patient, presenting a promising avenue for long-term value.
The FDA clearance is the fourth for Nanowear, consolidating its position as an innovator in remote diagnostics. SimpleSense-BP's approval is based on the four-decision tree algorithm, tested in various study arms across diverse geographies and demographic populations, aiming to replicate the diversity of the U.S. population.
Ken Ouriel, Chief Medical Officer of NAMSA, a MedTech clinical research organization, emphasizes the importance of technologies like SimpleSense in obtaining reliable measurements of a person's real-life vital statistics, eliminating biases introduced by factors like white coat syndrome. Continuous blood pressure monitoring, as offered by Nanowear's device, holds value not only in healthcare settings but also as a tool in clinical trials.
Nanowear's innovative approach to continuous blood pressure monitoring has the potential to transform clinical research platforms, providing sponsors with clinically reliable, trended data-driven insights derived from real-world conditions, including patients' homes and workplaces. This achievement signifies the company's commitment to advancing precision medicine through cutting-edge wearable technology.