BraveHeart wireless announces FDA clearance of the BraveHeart life sensor cardiac monitoring system

The BraveHeart™ life sensor cardiac monitoring system is now approved 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 —BraveHeart Wireless a innovator in clinical-quality biometric wearables, 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.

“The Life Sensor has the potential to significantly and positively impact patient care,” said Dave Shimkus, Vice President of Operations at BraveHeart Wireless. “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.”