Close

FDA approves Nanowear’s cloth-based diagnostic monitoring platform

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Related stories

CMS in US Launches WISeR Model to Enhance Original Medicare

The Centers for Medicare & Medicaid Services (CMS) is...

England GP IT Market Witnesses Shake-Up Unseen in 25 Years

England’s National Health Service, which is popularly known as...

Label Expansion In Alzheimers Gives GE HealthCare An Edge

The US Food and Drug Administration (FDA) has gone...

US Health Systems Accelerating AI Collaborations

US Health systems are speeding up their collaborations with...

Nanowear has secured class II 510(k) clearance from the US Food and Drug Administration (FDA) for its SimpleSENSE cloth-based diagnostic platform.

Claimed to be the first-of-its-kind, SimpleSENSE is a multi-parameter remote diagnostic undergarment and machine learning digital platform that simultaneously and synchronously monitors and evaluates the heart, lungs, and upper vascular system.

The SimpleSENSE platform, which is gender-neutral and size adjustable, is developed to replace the digital stethoscope, multi-channel Holter monitor, Capnogram respiration machine.and blood pressure cuff.

SimpleSENSE enables to capture over 100 million data points per patient per day

SimpleSENSE serves as a diagnostic monitoring system to remotely capture over 100 million data points per patient per day across cardiac, pulmonary, and circulatory biomarkers.

With a rise in demand for telemedicine and remote diagnostic monitoring, SimpleSENSE offers a digital tool to evaluate medical data and trends between these biomarkers in an innovative way.

Nanowear intends to continue its SimpleSENSE clinical trials in diagnosing worsening heart failure and Covid-19, in addition to near-term commercialisation of SimpleSENSE platform.

Nanowear co-founder and CEO Venk Varadan said: “SimpleSENSE marks the company’s second FDA 510(k) clearance and follows Nanowear’s strategy of continued data-driven differentiation in the connected-care and remote diagnostic market.

“In the face of the unexpected and unprecedented Covid-19 public health emergency, Nanowear began working collaboratively with FDA to evaluate a broadened indication for use for SimpleSENSE.

“Our platform can now efficiently serve the new need for remote diagnostics across primary care, acute illness and procedure, and chronic disease cases.”

In July 2019, Nanowear commenced NanoSENSE heart failure management and alert diagnostic validation study.

Nanowear is involved in the development of patented and cloth-based nanosensor technology for use in different applications, including cardiac, neurological, and industrial safety.

Latest stories

Related stories

CMS in US Launches WISeR Model to Enhance Original Medicare

The Centers for Medicare & Medicaid Services (CMS) is...

England GP IT Market Witnesses Shake-Up Unseen in 25 Years

England’s National Health Service, which is popularly known as...

Label Expansion In Alzheimers Gives GE HealthCare An Edge

The US Food and Drug Administration (FDA) has gone...

US Health Systems Accelerating AI Collaborations

US Health systems are speeding up their collaborations with...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back