Press Releases
Nanowear Announces FDA 510(k) Clearance for AI-enabled Continuous Blood Pressure Monitoring and Hypertension Diagnostic Management: SimpleSense-BP
January, 2024 - Nanowear, a leader in healthcare-at-home remote diagnostics, announced that its nanotechnology-enabled wearable and software platform, SimpleSenseTM, has received FDA 510(k) clearance for a novel AI-enabled Software-as-a-Medical Device (SaMD).
Nanowear Receives FDA 510(k) Platform Clearance to Implement Forthcoming AI-based Diagnostics in its Closed Loop Hospital-at-Home Network
September, 2021 - Nanowear, a leading hospital-at-home and remote diagnostic platform informed by proprietary cloth nanotechnology and AI, today announced that it received its third FDA 510(k) clearance and first software-only clearance as an end-to-end digital platform, illustrating unique capabilities available to enterprise customer channels across a broad spectrum of diagnostic and monitoring verticals.
Nanowear announces commercial distribution partnership in AI-based post-surgical recovery monitoring.
May, 2021 - Nanowear, the leading nanotechnology and AI-based remote diagnostic company, today announced a commercial distribution partnership with a world leading aesthetic and reconstructive surgical device-manufacturer, to enhance and optimize post-surgical recovery for both patients and surgeons.
Nanowear Receives FDA 510(k) Clearance for SimpleSENSE, a Cloth-Based Wearable Remote Diagnostic Monitoring Platform
November, 2020 - Nanowear, the leading connected-care and remote diagnostic platform, today announced it has received FDA Class II 510(k) clearance for a first-of-its-kind cloth-based diagnostic platform, SimpleSENSE. SimpleSENSE is a multi-parameter remote diagnostic undergarment and machine learning digital platform, which simultaneously and synchronously monitors and assesses the heart, lungs, and upper vascular system.
Nanowear Announces COVID-19 Remote Diagnostic Research Collaboration with New York City-Metro Health Systems
July, 2020 — Nanowear, the leading nanotechnology-based connected-care and remote diagnostic platform, today announced an expanded COVID-19 remote diagnostic research alliance with Hackensack Meridian Health Systems, the largest hospital system in New Jersey and Maimonides Medical Center in Brooklyn, NY.
Nanowear Announces Clinical Launch of NanoSENSE, a Heart Failure Management and Alert Diagnostic Validation Study
July, 2019 — Nanowear, the leading nanotechnology-based connected-care and remote monitoring platform, today announced the clinical launch of NanoSENSE, a Heart Failure Management and Alert Diagnostic Validation Study. The study will initially be conducted at Penn State Milton S. Hershey Medical Center and Hackensack Meridian Health Systems.
Nanowear Receives FDA Clearance For Its Transformative Remote Diagnostic Monitoring Device Differentiated By Novel Cloth-Based Nanosensor Technology (SimplECG™)
December, 2016 — Nanowear, an early stage developer of cloth-based diagnostic monitoring nanosensor technology, today announced that it has received FDA Class II 510(k) clearance for its first product, SimplECG™, a remote cardiac monitoring undergarment. SimplECG™ collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it to a web-based portal for review by a physician, by way of a mobile application. The initial version of the product is iPhone-based.
Nanowear Appoints Industry-Leading Experts To Its Newly Formed Advisory Board
December, 2014 — Nanowear, an emerging developer of wearable, textile-based diagnostic monitoring technology, today announced the appointment of leading medical and technology experts to its newly formed Advisory Board. The newly appointed Advisory Board will serve as a strategic resource to Nanowear as the Company continues product development and quality management in preparation for the U.S. Food and Drug Administration (FDA) approval process of its go-to-market product, a remote cardiac monitoring shirt for patients exhibiting symptoms of cardiovascular disease and potential ischemic events.
Nanowear Raises $1.5M Led By Social+Capital And MAS Holdings To Disrupt Remote Medical Diagnostic Monitoring
September, 2014 — Nanowear Inc., an early-stage developer of wearable, textile-based diagnostic monitoring technology, today announced a $1.5M seed investment led by The Social+Capital Partnership and MAS Holdings (Pvt.) Limited, with several influential angels also participating in the round. The seed investment will fund production scaling and continued testing / validation of the company’s go-to-market product, a remote cardiac monitoring wearable base layer, in preparation for the U.S. Food and Drug Administration’s (FDA) approval process.