Cardiosense Granted FDA Breakthrough Device Designation for Algorithm to Identify Risk of Decompensated Heart Failure

February 17, 2022—Cardiosense, Inc. announced it has received FDA Breakthrough Device designation for its novel algorithm designed to identify patients at risk for decompensated heart failure. According to the company, the algorithm analyzes data collected from the multisensor CardioTag device to noninvasively assess pulmonary capillary wedge pressure, a measure that currently can only be captured through an invasive catheterization procedure.

The CardioTag device is the company’s proprietary wearable device that will couple with the novel algorithm to enable clinicians to identify signs of acute heart failure sooner and implement interventions.

The FDA Breakthrough Device designation, which is awarded only to breakthrough technologies that have the potential to provide more effective treatment, will allow for expedited regulatory review of the algorithm, says Cardiosense.

Cardiosense explained that the Breakthrough Device designation was supported in part by National Institutes of Health–funded research led by Liviu Klein, MD, Lead Clinical Advisor at Cardiosense, in collaboration with Omer Inan, PhD, and Mozziyar Etemdai, MD.

“Cardiosense’s technology has the potential to be a revolutionary advance in the noninvasive assessment of the hemodynamic state of patients with heart failure,” commented Dr. Klein in the company’s announcement. “One of the greatest challenges in the management of patients with chronic heart failure is forecasting and preventing the development of acute worsening leading to hospitalizations. This technology could be used to identify time periods at risk and opportunities for intervention for patients with heart failure.” Dr. Klein is also Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension & Heart Transplantation at University of California San Francisco, in San Francisco, California.

Dr. Inan is a cofounder of Cardiosense and the Linda J. and Mark C. Smith Chair in Bioscience and Bioengineering at Georgia Institute of Technology, in Atlanta, Georgia, and Dr. Etemadi is Medical Director, Advanced Technologies at Northwestern Medicine in Chicago, Illinois.