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PCA 500™ Receives FDA Clearance for Acute Care Applications: Advancing 12-Lead ECG Technology

Wednesday, February 14, 2024

QT Medical has recently announced that its PCA 500™ device has received 510(k) clearance from the FDA for use in acute care settings, including hospitals, intensive care units, emergency rooms, and ambulances. This clearance marks a significant expansion of the PCA 500™'s indication for use, which was originally cleared in 2018 for professional and personal use by adults in non-acute care settings and later in 2022 for infants, children, and adolescents.

The PCA 500™ device, developed with funding from the National Institutes of Health (NIH), features patented QHeart™ sensors and a compact recorder, providing a digital, mobile, and cloud-based ECG management solution. Its ease of use and portability have led to widespread adoption across various sectors, including airlines, telehealth practices, clinics, skilled nursing facilities, clinical trials, and schools.

With its recent FDA clearance for use in acute care settings, the PCA 500™ holds promise for improving efficiency and accuracy in environments where prompt and reliable ECG recordings are essential. By facilitating quicker diagnosis and treatment initiation, particularly in prehospital care and emergency rooms, the PCA 500™ has the potential to enhance patient outcomes. Its pre-positioned QHeart sensors and automated periodic recording enable rapid and accurate ECG monitoring, aiding in the early detection of clinical changes.

QT Medical intends to promote the use of the PCA 500™ in prehospital care by paramedics and in emergency rooms, emphasizing its ability to streamline ECG recording processes and improve adherence to clinical guidelines. This development underscores the importance of advanced ECG solutions in optimizing cardiac care delivery and enhancing patient outcomes across diverse healthcare settings.