FDA grants Breakthrough designation for novel heart monitor

CardioStory, a digital therapeutics start-up that employs non-invasive devices and data analytics to help treat patients, has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its non-invasive monitoring solution for heart failure.

This medical device provides readings to both inpatients and outpatients, enabling better management of their condition, with the aim of reducing the need for hospitalisations and re-hospitalisations.

The Breakthrough Devices Program was created to provide patients and providers with access to medical devices by speeding up their development, assessment and review, according to the FDA. A device that is granted a breakthrough designation typically means that FDA has a reasonable expectation that this technology can provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

Elevated heart filling pressure is the main reason for hospitalisation in patients with heart failure and keeping it within an optimal range is an important target for therapy. However, monitoring filling pressure is challenging. The gold standard is using an invasive heart catheter (Pulmonary Capillary Wedge Pressure, or PCWP), which is not proper for repeated use due to its invasive nature. Using ultrasound with echocardiography is the most used approach to access filling pressure too, but it requires experienced operators and is time-consuming. Diuretics pills are the primary tool for treating elevated filling pressure.

CardioStory is developing a cardiovascular disease diagnosis and remote patient monitoring platform based on this device. The accuracy of the NIFP device has been evaluated in a study that demonstrated an 89% accuracy compared to PCWP. This accuracy is promising to outperform ultrasound and physical examination by experienced physicians.

Dr. Junhao Hu, CEO, and founder of CardioStory, said: "This important breakthrough designation will help accelerate FDA's final review of our product. We look forward to introducing a solution that will support a better quality of life for patients and reduce healthcare expenditures. With the breakthrough designation, we shall speed up the process to bring the device to more patients.”

Shawn Zhuang, co-founder of CardioStory who led the development of the new device, added: “This device can be used as a point of care device to support the evaluation of congestion to enhance the capability of primary care, nursing facilities, emergency departments, and hospital wards. It also can be used at home for remote monitoring. It is helpful to protect the vulnerable heart failure patient by offering a novel solution to monitor their vital condition.”