The FDA has granted 501(k) clearance to BodyPort for its cardiovascular monitor that tracks patients with fluid management related heart conditions such as kidney disease and heart failure. According to the CDC, over 6 million adults in the US suffer from heart failure, resulting in over 12 million clinical visits and approximately 1.2 million hospitalizations annually. 90% of these hospitalizations are said to be the result of hemodynamic changes causing fluid accumulation. Typically, weight gain is the standard for non-invasive detection of fluid changes. However, Bodyport has developed a scale to measure fluid changes alternatively. To use the device, individuals are instructed to stand on the scale barefoot, where the scale will operate immediately. The cardiac scale measures body weight, heart rate, center of pressure, and peripheral impedance through the feet of the user standing on the scales surface to measure fluid changes.
The impedance signal, which is regulated by fluctuations in fluid levels and blood flow in the lower half of the body, represents the electrical resistance of the lower body and enables the measurement of parameters like heart rates and vascular impedance. The scale monitors the user’s impedance via four battery-generated electrodes placed on the top surface of the device. Furthermore, four load cells are located in each of the scale’s corners to track the static and dynamic loads that the user’s body exerts on it. The four load cells then measure the center of pressure and body weight. The device collects information and then displays the results on the screen of the device.
The device is intended for individuals above the age of 21 and for individuals under 180 kg or 397 lbs. The FDA conducted a variety of tests in order to examine the legitimacy of the device. The testing conducted concerned its biocompatibility, electrical safety and electromagnetic compatibility, software verification and validation, human factors validation, and its implantable cardiac device compatibility. For testing of a clinical nature, the device was found to have an accurate pulse and peripheral impedance evaluations. In their approval letter, the FDA stated, “the non-clinical and clinical data support the safety of the Bodyport Cardiac Scale and the hardware and software verification and validation demonstrate that the device should perform as intended in the specified use conditions.”
Bodyport has maintained that the data created by the device must be considered in collaboration with all other clinical data to determine a patient’s condition as the scale does not generate real-time alarms worthy of consideration for the user or their healthcare professional. The FDA confirmed that the device will only be given to individuals based on prescriptions granted by their clinicians.