Flosonics Medical has secured another FDA 510(k) clearance for its FloPatch wearable Doppler ultrasound, enhancing real-time fluid monitoring in ICUs.
Flosonics Medical has announced it received a new FDA 510(k) clearance (K252810) for its FloPatch (FP120), marking a significant milestone in the evolution of wearable hemodynamic monitoring. The updated clearance underscores the company’s commitment to refining its wireless Doppler ultrasound technology, designed to provide real-time assessment of blood flow in critically ill patients.
The FloPatch is a first-of-its-kind wearable sensor that adheres to a patient’s neck, utilizing continuous wave (CW) Doppler ultrasound to monitor blood flow in the carotid artery. This non-invasive tool provides clinicians in intensive care units (ICUs) and emergency departments (EDs) with objective data to guide fluid resuscitation—a critical decision-making process in treating sepsis and other forms of shock.