Technology | Stethoscopes | November 19, 2015

Smart ECG Stethoscope Attachment Improves the Cardio-Diagnostic Processes

FDA-cleared device combines ECG, digital auscultation and mobile app integration with any existing stethoscope

Rijuven, CardioSleeve for Pediatrics, FDA clearance, stethoscopes

Image courtesy of Rijuven


November 19, 2015 — Rijuven announced the launch of CardioSleeve for Pediatrics, the first U.S. Food and Drug Administration (FDA)-cleared device that adds electrocardiogram (ECG) capabilities to transform any existing stethoscope into a smart, mobile-connected device. The system is complete with three-lead ECG, digital auscultation and real-time digital analysis optimized for pediatric care. With CardioSleeve, pediatricians and clinicians can quickly and accurately visualize heart sound, analyze for arrhythmia or murmur, and identify heart failure.

Through the synchronization of digital heart sound with ECG, CardioSleeve for Pediatrics makes all-new functionality possible, such as advanced murmur detection analysis at times when restless patients, noisy environments and rapid heart rate can make examinations challenging. CardioSleeve murmur detection analysis aids in the diagnosis of pathological and physiological heart sounds in patients as young as infants, at heart rates up to 180 beats per minute.

Pediatricians and clinicians simply attach the CardioSleeve to an existing stethoscope. The device quickly and accurately acquires the digital acoustic and electric footprints of the heart and transmits them to a mobile device for real-time analysis. This allows for the creation of the Systolic Performance Index, a measure of ejection fraction, critical to identifying heart failure.

CardioSleeve for Pediatrics and its companion mobile app features:

  • Digital auscultation with ECG;
  • Murmur detection and analysis at beats up to 180 BPM;
  • High fidelity three-lead ECG;
  • Systolic Performance Index;
  • Digital caliper;
  • FDA clearance for both device and analysis;
  • HIPAA-secure data transfer and cloud-based electronic medical record (EMR);
  • Wireless Bluetooth connectivity;
  • IOS, Android and PC compatibility;
  • Easy attachment to any traditional stethoscope; and
  • Dry-contact and biocompatible surfaces.

CardioSleeve for Pediatrics is part of the Rijuven i2Dtx platform. i2Dtx is a comprehensive, portable, cloud-based medical device platform for heart, lung, vital signs, imaging and lab clinical assessments for any physical examination.

The i2DTX platform includes a CardioSleeve and connected devices including an otoscope, pulse ox, IR thermometer and blood pressure cuff. Optional additions include a weight scale, spirometer, ultrasound, and blood glucose monitor. All devices can be wirelessly deployed to assess patients at any point of care. i2Dtx connects vitals, diagnostic, and lab devices with live notes, real-time consults, high definition (HD) photos for visual exams and a complete EMR report both in the facility and remotely.

For more information: www.rijuven.com


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