Monday, July 1, 2019

BraveHeart Wireless Announces FDA Clearance of the BraveHeart Life Sensor Cardiac Monitoring System

• The BraveHeart™ Life Sensor Cardiac Monitoring system has

been cleared for use in health care settings.


• The Life Sensor monitoring system securely captures

patients’ heart rate and EKG data, and transmits the data to health care

providers in real time.


• More than 28 million Americans diagnosed with heart

disease may benefit—with this number growing each year.





NASHUA, New Hampshire — June 19, 2019 — BraveHeart Wireless

Inc., a leading innovator in clinical-quality biometric wearables, today

announced that the company received clearance from the U.S. Food and Drug

Administration (FDA) for the BraveHeart™ Life Sensor Cardiac Monitoring system.


The Life Sensor Cardiac Monitoring system is intended for

use by health care professionals within a health care setting. The system captures

heart rate and EKG data using a Life Sensor electrode affixed to a patient’s

skin and continuously transmits the data from the electrode to an application

on an iOS device, where the data can be reviewed by health care professionals.


The Life Sensor Cardiac Monitoring system is a milestone

product; it is the first product of its kind built on the BraveHeart Wireless Internet

of Things (IoT) “open” platform. BraveHeart Wireless continues to develop

additional health-related products on this platform as it works closely with

key partners to configure its platform for targeted use models.


“Prior to the Life Sensor, people with the need for truly

wireless heart-monitoring had limited options. Now, health care professionals

can use the Life Sensor to quickly and wirelessly receive relevant,

clinical-quality and actionable heart rate and EKG data—even as a person is

waiting to be admitted to a health care facility,” said Steve McCalmont, CEO of

BraveHeart Wireless Inc.


“The Life Sensor has the potential to significantly and

positively impact patient care,” said Dave Shimkus, Vice President of

Operations at BraveHeart Wireless Inc. “The FDA ensured the Life Sensor cardiac

monitoring system meets the FDA’s regulatory requirements for safety and

effectiveness. We look forward to seeing the BraveHeart Life Sensor platform

widely used in a variety of health care settings, and to working with our

partners to develop additional products.”


ABOUT THE BRAVEHEART LIFE SENSOR CARDIAC MONITORING SYSTEM


The Life Sensor Cardiac Monitoring system introduces a

proprietary and pioneering set of features to the cardiac monitoring segment,

including these key features:


• Everyday-wear form factor. The Life Sensor Cardiac Monitoring

system is the smallest, most comfortable, clinical-quality sensor patch on the

market.


• Patent-pending technology. The Life Sensor

Cardiac Monitoring system employs both passive and active sensors. Initial patents

have been filed on BraveHeart Wireless’s critical method of multiplexing

multiple sensors on a single patch.


ABOUT THE

BRAVEHEART LIFE SENSOR IOT OPEN PLATFORM


The BraveHeart Life Sensor Internet of Things open platform

is used to power the FDA-cleared Life Sensor Cardiac Monitoring system. The

platform’s additional features include:


• OEM / partner channel model. The seamless

integration potential of the Life Sensor Cardiac Monitoring system is designed

to accelerate its penetration into multiple medical segments, from the solo

researcher to large medical device companies. 


• Widest array of sensors on a single patch. Because of the

number and type of sensors that are built into the Life Sensor system, health

care partners can rely on the Life Sensor to cover patient needs in multiple

health care sectors.


• Open-platform. The Life Sensor

Cardiac Monitoring system harnesses a modern, cloud-based RESTful API and

Modular hardware platform. The Life Sensor Cardiac Monitoring system is

designed to transmit continuous data to enable telemedicine and other modalities.


LIFE SENSOR CARDIAC MONITORING SYSTEM INDICATIONS


In the United States, 28.2 million adults are currently

diagnosed with heart disease—and this number continues to grow. Every year,

about 735,000 Americans suffer a heart attack, and heart disease has now become

the leading cause of death for men and women in the United States, according to

the Centers for Disease Control.


The chances of survival are greater when emergency treatment

begins quickly. The Life Sensor Cardiac Monitoring system is designed to

provide fast application and access to a patient’s heart rate and EKG data.


The Life Sensor Cardiac Monitoring system is comprised of

several components, including a single-use, self-adhesive patch that can be

attached to a patient’s skin directly above the heart. This patch is equipped

with a sensor that can capture a patient’s heart rate and EKG data and

wirelessly transmit this data via BLE (Bluetooth Low Energy) in real-time to an

application on an iOS device, where the data can be reviewed by health care

professionals.


ABOUT BRAVEHEART WIRELESS


BraveHeart Wireless Inc. is a privately held medical device

company focused on developing and commercializing innovative technologies. The company

is headquartered in Nashua, New Hampshire. For further information, visit www.BraveHeart.life. Follow us on

Twitter at @BraveHeartTech and on Facebook at @BraveHeartWireless.


BraveHeart™ Life Sensor is a

trademark of BraveHeart Wireless Inc.


ABOUT THE FDA


The FDA, an agency within the U.S. Department of Health and

Human Services, promotes and protects the public health by, among other things,

assuring the safety, effectiveness, and security of human and veterinary drugs,

vaccines and other biological products for human use, and medical devices. The

agency also is responsible for the safety and security of our nation’s food

supply, cosmetics, dietary supplements, products that give off electronic

radiation, and for regulating tobacco products.

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