Bardy Diagnostics™ Selected as a Winner of the Children's National Pediatric Medical Device Innovation Competition
SEATTLE, Sept. 26, 2018 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor ("CAM™"), the world's first P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device, announced it was selected as one of six winners of the "Make Your Medical Device Pitch for Kids!" Competition hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National Health System.
Eleven finalists from a field of 45 worldwide submissions were selected to present their products this past weekend at the Sixth Annual Pediatric Device Innovation Symposium. A distinguished judging panel of industry experts awarded BardyDx a $25,000 prize based on the CAM patch's pediatric-friendly design, innovative P-wave centric technology, and potential to address significant unmet needs in pediatric healthcare.
"BardyDx is excited to receive this award and this honor reinforces our commitment to the advancement of pediatric cardiology care," said Ken Nelson, BardyDx Chief Commercial Officer. "The CAM patch is one of only a few FDA-approved products that is commercially available for patients weighing 10 kg (22 lbs) or more. This award prize will be used towards development efforts to expand our labeling to cover all of pediatrics and make the CAM patch the gold-standard for pediatric ambulatory cardiac monitoring."
The competition is one of the highlights of this year's symposium, themed "Using Real-World Evidence to Drive Pediatric Innovation," organized by Children's National to bring together medical device innovators, investors, researchers, clinicians and policy makers to advance pediatric healthcare and address the unmet surgical and medical device needs of children. Along with the theme, BardyDx's body of clinical evidence recently expanded, highlighting the significance of the CAM patch's P-wave focused clinical value in this month's issue of the American Heart Journal.
The published results of the head-to-head comparison study with the iRhythm Zio® XT patch, "Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity," (Am Heart J 2018; 203:109-117) revealed that the CAM patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients over the Zio XT patch primarily due to the enhanced design of the CAM patch to provide unparalleled clarity of tracings. These promising results have spurred interest in additional CAM patch studies to drive innovation in the pediatric population, especially in the younger sub-groups, where off-label use of devices is common.
"We are honored to recognize these outstanding innovations and we already envision the ways they can advance care for children," said Kolaleh Eskandanian, PhD, Vice President and Chief Innovation Officer at Children's National and Principal Investigator of the National Capital Consortium for Pediatric Device Innovation (NCC-PDI).
About Children's National Health System:
Children's National Health System, based in Washington, D.C., has served the nation's children since 1870. Children's National is one of the nation's Top 5 pediatric hospitals and, for a second straight year, is ranked No. 1 in newborn care, as well as ranked in all specialties evaluated by U.S. News & World Report. It has been designated two times as a Magnet® hospital, a designation given to hospitals that demonstrate the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty outpatient centers in the D.C. Metropolitan area, including the Maryland suburbs and Northern Virginia. Home to the Children's Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National is the seventh-highest NIH-funded pediatric institution in the nation. Children's National is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels.
About Bardy Diagnostics:
Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac patch and other monitors to the industry. The company's CAM patch is a non-invasive, P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance for men, women, and children through its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. The innovative and broadly-patented technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the signal of the ECG waveform that is essential for accurate arrhythmia diagnosis. Additional information can be found at the recently launched redesign of the BardyDx corporate website at www.bardydx.com.
Bardy Diagnostics, Inc.