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07-02-2019, 12:52 AM
BraveHeart Wireless Announces FDA Clearance of the BraveHeart Life Sensor Cardiac Monitoring System
• The BraveHearthttps://s.w.org/images/core/emoji/12.0.0-1/72x72/2122.png Life Sensor Cardiac Monitoring system hasbeen cleared for use in health care settings.
• The Life Sensor monitoring system securely capturespatients’ heart rate and EKG data, and transmits the data to health careproviders in real time.
• More than 28 million Americans diagnosed with heartdisease may benefit—with this number growing each year.
https://www.medgadget.com/wp-content/uploads/2019/07/BraveHeart.jpg
NASHUA, New Hampshire — June 19, 2019 — BraveHeart WirelessInc., a leading innovator in clinical-quality biometric wearables, todayannounced that the company received clearance from the U.S. Food and DrugAdministration (FDA) for the BraveHearthttps://s.w.org/images/core/emoji/12.0.0-1/72x72/2122.png Life Sensor Cardiac Monitoring system.
The Life Sensor Cardiac Monitoring system is intended foruse by health care professionals within a health care setting. The system capturesheart rate and EKG data using a Life Sensor electrode affixed to a patient’sskin and continuously transmits the data from the electrode to an applicationon an iOS device, where the data can be reviewed by health care professionals.
The Life Sensor Cardiac Monitoring system is a milestoneproduct; it is the first product of its kind built on the BraveHeart Wireless Internetof Things (IoT) “open” platform. BraveHeart Wireless continues to developadditional health-related products on this platform as it works closely withkey partners to configure its platform for targeted use models.
“Prior to the Life Sensor, people with the need for trulywireless heart-monitoring had limited options. Now, health care professionalscan use the Life Sensor to quickly and wirelessly receive relevant,clinical-quality and actionable heart rate and EKG data—even as a person iswaiting to be admitted to a health care facility,” said Steve McCalmont, CEO ofBraveHeart Wireless Inc.
“The Life Sensor has the potential to significantly andpositively impact patient care,” said Dave Shimkus, Vice President ofOperations at BraveHeart Wireless Inc. “The FDA ensured the Life Sensor cardiacmonitoring system meets the FDA’s regulatory requirements for safety andeffectiveness. We look forward to seeing the BraveHeart Life Sensor platformwidely used in a variety of health care settings, and to working with ourpartners to develop additional products.”
ABOUT THE BRAVEHEART LIFE SENSOR CARDIAC MONITORING SYSTEM
The Life Sensor Cardiac Monitoring system introduces aproprietary and pioneering set of features to the cardiac monitoring segment,including these key features:
• Everyday-wear form factor. The Life Sensor Cardiac Monitoringsystem is the smallest, most comfortable, clinical-quality sensor patch on themarket.
• Patent-pending technology. The Life SensorCardiac Monitoring system employs both passive and active sensors. Initial patentshave been filed on BraveHeart Wireless’s critical method of multiplexingmultiple sensors on a single patch.
ABOUT THEBRAVEHEART LIFE SENSOR IOT OPEN PLATFORM
The BraveHeart Life Sensor Internet of Things open platformis used to power the FDA-cleared Life Sensor Cardiac Monitoring system. Theplatform’s additional features include:
• OEM / partner channel model. The seamlessintegration potential of the Life Sensor Cardiac Monitoring system is designedto accelerate its penetration into multiple medical segments, from the soloresearcher to large medical device companies.
• Widest array of sensors on a single patch. Because of thenumber and type of sensors that are built into the Life Sensor system, healthcare partners can rely on the Life Sensor to cover patient needs in multiplehealth care sectors.
• Open-platform. The Life SensorCardiac Monitoring system harnesses a modern, cloud-based RESTful API andModular hardware platform. The Life Sensor Cardiac Monitoring system isdesigned 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 currentlydiagnosed with heart disease—and this number continues to grow. Every year,about 735,000 Americans suffer a heart attack, and heart disease has now becomethe leading cause of death for men and women in the United States, according tothe Centers for Disease Control.
The chances of survival are greater when emergency treatmentbegins quickly. The Life Sensor Cardiac Monitoring system is designed toprovide fast application and access to a patient’s heart rate and EKG data.
The Life Sensor Cardiac Monitoring system is comprised ofseveral components, including a single-use, self-adhesive patch that can beattached to a patient’s skin directly above the heart. This patch is equippedwith a sensor that can capture a patient’s heart rate and EKG data andwirelessly transmit this data via BLE (Bluetooth Low Energy) in real-time to anapplication on an iOS device, where the data can be reviewed by health careprofessionals.
ABOUT BRAVEHEART WIRELESS
BraveHeart Wireless Inc. is a privately held medical devicecompany focused on developing and commercializing innovative technologies. The companyis headquartered in Nashua, New Hampshire. For further information, visit www.BraveHeart.life (http://www.braveheart.life/). Follow us onTwitter at @BraveHeartTech and on Facebook at @BraveHeartWireless.
BraveHearthttps://s.w.org/images/core/emoji/12.0.0-1/72x72/2122.png Life Sensor is atrademark of BraveHeart Wireless Inc.
ABOUT THE FDA
The FDA, an agency within the U.S. Department of Health andHuman 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. Theagency also is responsible for the safety and security of our nation’s foodsupply, cosmetics, dietary supplements, products that give off electronicradiation, and for regulating tobacco products.
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• The BraveHearthttps://s.w.org/images/core/emoji/12.0.0-1/72x72/2122.png Life Sensor Cardiac Monitoring system hasbeen cleared for use in health care settings.
• The Life Sensor monitoring system securely capturespatients’ heart rate and EKG data, and transmits the data to health careproviders in real time.
• More than 28 million Americans diagnosed with heartdisease may benefit—with this number growing each year.
https://www.medgadget.com/wp-content/uploads/2019/07/BraveHeart.jpg
NASHUA, New Hampshire — June 19, 2019 — BraveHeart WirelessInc., a leading innovator in clinical-quality biometric wearables, todayannounced that the company received clearance from the U.S. Food and DrugAdministration (FDA) for the BraveHearthttps://s.w.org/images/core/emoji/12.0.0-1/72x72/2122.png Life Sensor Cardiac Monitoring system.
The Life Sensor Cardiac Monitoring system is intended foruse by health care professionals within a health care setting. The system capturesheart rate and EKG data using a Life Sensor electrode affixed to a patient’sskin and continuously transmits the data from the electrode to an applicationon an iOS device, where the data can be reviewed by health care professionals.
The Life Sensor Cardiac Monitoring system is a milestoneproduct; it is the first product of its kind built on the BraveHeart Wireless Internetof Things (IoT) “open” platform. BraveHeart Wireless continues to developadditional health-related products on this platform as it works closely withkey partners to configure its platform for targeted use models.
“Prior to the Life Sensor, people with the need for trulywireless heart-monitoring had limited options. Now, health care professionalscan use the Life Sensor to quickly and wirelessly receive relevant,clinical-quality and actionable heart rate and EKG data—even as a person iswaiting to be admitted to a health care facility,” said Steve McCalmont, CEO ofBraveHeart Wireless Inc.
“The Life Sensor has the potential to significantly andpositively impact patient care,” said Dave Shimkus, Vice President ofOperations at BraveHeart Wireless Inc. “The FDA ensured the Life Sensor cardiacmonitoring system meets the FDA’s regulatory requirements for safety andeffectiveness. We look forward to seeing the BraveHeart Life Sensor platformwidely used in a variety of health care settings, and to working with ourpartners to develop additional products.”
ABOUT THE BRAVEHEART LIFE SENSOR CARDIAC MONITORING SYSTEM
The Life Sensor Cardiac Monitoring system introduces aproprietary and pioneering set of features to the cardiac monitoring segment,including these key features:
• Everyday-wear form factor. The Life Sensor Cardiac Monitoringsystem is the smallest, most comfortable, clinical-quality sensor patch on themarket.
• Patent-pending technology. The Life SensorCardiac Monitoring system employs both passive and active sensors. Initial patentshave been filed on BraveHeart Wireless’s critical method of multiplexingmultiple sensors on a single patch.
ABOUT THEBRAVEHEART LIFE SENSOR IOT OPEN PLATFORM
The BraveHeart Life Sensor Internet of Things open platformis used to power the FDA-cleared Life Sensor Cardiac Monitoring system. Theplatform’s additional features include:
• OEM / partner channel model. The seamlessintegration potential of the Life Sensor Cardiac Monitoring system is designedto accelerate its penetration into multiple medical segments, from the soloresearcher to large medical device companies.
• Widest array of sensors on a single patch. Because of thenumber and type of sensors that are built into the Life Sensor system, healthcare partners can rely on the Life Sensor to cover patient needs in multiplehealth care sectors.
• Open-platform. The Life SensorCardiac Monitoring system harnesses a modern, cloud-based RESTful API andModular hardware platform. The Life Sensor Cardiac Monitoring system isdesigned 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 currentlydiagnosed with heart disease—and this number continues to grow. Every year,about 735,000 Americans suffer a heart attack, and heart disease has now becomethe leading cause of death for men and women in the United States, according tothe Centers for Disease Control.
The chances of survival are greater when emergency treatmentbegins quickly. The Life Sensor Cardiac Monitoring system is designed toprovide fast application and access to a patient’s heart rate and EKG data.
The Life Sensor Cardiac Monitoring system is comprised ofseveral components, including a single-use, self-adhesive patch that can beattached to a patient’s skin directly above the heart. This patch is equippedwith a sensor that can capture a patient’s heart rate and EKG data andwirelessly transmit this data via BLE (Bluetooth Low Energy) in real-time to anapplication on an iOS device, where the data can be reviewed by health careprofessionals.
ABOUT BRAVEHEART WIRELESS
BraveHeart Wireless Inc. is a privately held medical devicecompany focused on developing and commercializing innovative technologies. The companyis headquartered in Nashua, New Hampshire. For further information, visit www.BraveHeart.life (http://www.braveheart.life/). Follow us onTwitter at @BraveHeartTech and on Facebook at @BraveHeartWireless.
BraveHearthttps://s.w.org/images/core/emoji/12.0.0-1/72x72/2122.png Life Sensor is atrademark of BraveHeart Wireless Inc.
ABOUT THE FDA
The FDA, an agency within the U.S. Department of Health andHuman 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. Theagency also is responsible for the safety and security of our nation’s foodsupply, cosmetics, dietary supplements, products that give off electronicradiation, and for regulating tobacco products.
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