The Breakthrough Device designation was supported in part by National Institutes of Health funded research led by Dr. Liviu Klein, M.D., M.S., Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension & Heart Transplantation at UCSF and Lead Clinical Advisor at Cardiosense, in collaboration with Dr. Inan and Dr. Etemadi. "Cardiosense's technology has the potential to be a revolutionary advance in the noninvasive assessment of the hemodynamic state of patients with heart failure," said Dr. Klein. "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."


About Cardiosense

Cardiosense is building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes. For more information, visit: www.cardiosense.com.


About the FDA Breakthrough Device Program
The FDA Breakthrough Device program enables expedited regulatory assessment of novel technologies with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.


SOURCE Cardiosense

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