BraveHeart Wireless Receives FDA Clearance for its Life Sensor Cardiac Monitoring system

BraveHeart Wireless Inc. received FDA clearance for its BraveHeart Life Sensor.

Image: BraveHeart

BraveHeart Wireless Inc., a New Hampshire-based leading innovator in clinical-quality biometric wearables, received FDA clearance for its BraveHeart Life Sensor Cardiac Monitoring system.

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Intended for use by health care professionals within a health care setting, the Life Sensor Cardiac Monitoring system captures heart rate and EKG data using a Life Sensor electrode affixed to a patient’s skin. The system then transmits the data from the electrode to an application on an iOS device, where the data can be reviewed by health care professionals.

This milestone product is the first of its kind to be 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.

Related Cambridge Heartwear Announces Release of ‘Heartsense Monitor,’ the First AI-Driven Wearable Heart Monitor

Image: BraveHeart

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.

“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.”

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Sam Draper
July 8, 2019

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