Nanowear Announces FDA 510(k) Clearance for AI-enabled Continuous Blood Pressure Monitoring and Hypertension Diagnostic Management: SimpleSense-BP

NEW YORK, NY, January 4, 2024 – Nanowear, a leader in healthcare-at-home remote diagnostics, announced that its nanotechnology-enabled wearable and software platform, SimpleSense™, has received FDA 510(k) clearance for a novel AI-enabled Software-as-a-Medical Device (SaMD). As the first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic, SimpleSense-BP provides a transformational tool in clinical diagnostic management of hypertension and is additive to the wearable platform’s previously cleared cardiopulmonary diagnostics.

“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 wearable, and data service solutions that find product market fit with the following three attributes: at-home, utilizing AI, and a proven team that executes,” says Venk Varadan, CEO and Co-founder of Nanowear, emphasizing the company’s distinction as the world’s only nanotechnology-based embedded sensor platform fueling irreproducible AI algorithms. “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.”

With its fourth FDA 510(k) clearance, alongside 13 awarded and 12 pending patents covering its nanotechnology, scaled nanosensor manufacturing, multi-parametric wearable, software platform, ingestion pipeline, and AI algorithms in a closed-loop ecosystem, Nanowear’s SimpleSenseTM is uniquely positioned in the market: the platform is indicated for use at-home, in healthcare facilities, and clinical research. The novel 4-decision tree algorithmic model, SimpleSense-BP, was tested in three study arms with both training and validation performed in independent geographies and demographic populations mirroring the most recent US census and generalizability to the entire hypertensive population. SimpleSense-BP is validated to track changes of > +/- 15mmHg systolic and +/- 10mmHg diastolic blood pressures over a continuous recording period across all classes of hypertension, via its wearable undergarment and AI platform.

NAMSA, the leading cardiovascular MedTech clinical research organization worldwide, sees Nanowear’s most recent clearance and indication for use as differentiating in customizing clinical research, a $50bn+ market with significant cost increases and requisite emphasis on real-world data reliability since the pandemic. “We often talk about whitecoat syndrome limiting our ability to understand the effect of therapeutics in blood pressure or other cardiopulmonary assessments. Whitecoat syndrome is just another word for ‘real-world’ living. Just as a patient’s blood pressure may be high in a 30 second reading due to whitecoat syndrome, the same patient may reduce their blood pressure by breathing calmly for five minutes before the 30 second reading. So, what are we actually learning about that individual patient or the therapeutic applied?” says NAMSA’s Chief Medical Officer, Ken Ouriel MD. “To date, existing healthcare wearables and software platforms are either restricted in scope and time; or are unreliable and unvalidated for what they can diagnose during ‘real-world’ conditions. Nanowear’s continuous device, software platform, and AI algorithms, can transform the way clinical research platforms operate. Efficiency, access, diversity, and standardization across geographies can be enhanced while significantly lowering trial costs. Importantly, sponsors would be able to receive clinically reliable and trended data driven insights; data from the real world; their patients’ homes, their workplace, and a myriad of other settings that comprise everyday life,” Dr. Ouriel concluded.

Nanowear, winner of the 2023 Innovation Pitch Challenge by The American College of Cardiology (ACC), organized in partnership with the National Heart, Lung, and Blood Institute (NHLBI), was 1 of 5 companies selected for the 2023 HeartX cohort, powered by Medaxiom (an ACC company) and Healthtech Arkansas. Joe Sasson, PhD, MedAxiom’s chief commercial officer and executive vice president of Ventures, recognizes the transformative nature of AI-enabled continuous blood pressure and home-based diagnostics for the 100M+ Americans with hypertension. “SimpleSense-BP’s continuous AI algorithm uses software quality management to mitigate against human error and other complexities of hypertension management, and it incorporates known confounders such as age, height, weight, ethnicity, and breathing rate as algorithmic inputs,” notes Sasson. “With more than 100 real-world examples in validation, this AI and home-based digital health platform offers collaborative intelligence to cardiologists, clinical researchers, and the empowered consumer, ultimately improving care pathways for this critical disease state. Additionally, the technology allows cardiovascular programs to achieve an increased frequency of data collection while using fewer staff and providing an improved patient experience, which are meaningful benefits for all cardiovascular organizations today.”

ABOUT NANOWEAR

Nanowear is a leading healthcare-at-home remote diagnostics company providing a smarter way to collect and analyze cardiopulmonary data at-home. Its end-to-end software, mobile, and machine learning powered platform is a radical leap forward in clinical research and virtual care, empowering physician decision-making with scored, clinical-grade diagnostic data through patented nanotechnology sensors that capture high-fidelity signals. To learn more, visit www.nanowearinc.com

ABOUT SIMPLESENSE™

SimpleSense™ is an FDA cleared, AI-enabled digital platform and wearable device that captures and analyzes 85+ unique biomarker data points across the heart, lungs, hemodynamic, and central vascular system. The platform provides high quality, continuous and time synchronous biometric data, aggregating millisecond by millisecond cardiopulmonary assessments to assist medical professionals in remote patient management. Utilizing proprietary nanosensors and algorithms, SimpleSense™ is the world’s first all-in-one wearable platform, replacing first line diagnostic tools including the blood pressure line, digital stethoscope, multi-channel ECG, hemodynamic monitor, pulse oximeter, spirometer, and actigraphy monitors.

ABOUT NAMSA

Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; market research and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. Web: namsa.com

Media Contact:
Rachel Reed
Director, Marketing and Communications
press@nanowearinc.com