China
January 1, 2022
Endocrinology
January 1, 2022ivWatch & VitalPatch Now Cleared by FDA
IV Placement Sites to avoid leakage, now cleared by FDA
The ivWatch gained FDA authorization for its SmartTouch sensor that recognizes peripheral IV infiltration and extravasation events.
Even though it is slightly unusual, these can be challenging to notice, and a late acknowledgment can lead to grave outcomes. The SmartTouch sensor can alert physicians that something is incorrect, sometimes hours before a clinician would discern any visual or tactile variations on the patient’s body.
The sensor, which is now cleared in Europe, is a single-use disposable device that can be utilized on patients of any age, including the neonatal intensive care unit
Clinicians can benefit from additional options from locating where to place the IV, especially relevant for neonates, choosing longer dwell times, and maintaining an eye on active patients during walking times.
The design, which uses visible and near-infrared light to penetrate the skin, can be utilized alongside the ivWatch Patient Monitor that algorithmically interprets the optical signatures of tissue nearby the IV site while compensating for patient movements.
The system can identify changes as small as .2 mL of IV fluid, with an average detection volume of 2.02 mL. Any adverse situations are immediately communicated to the clinical team. The adhesive on the backside of the sensor is breathable, leading to insignificant irritation and compatibility with current IV dressings.(1)
VitalPatch Wins FDA Emergency Use Authorization for Cardiac Monitoring in COVID Patients
VitalConnect announced FDA Emergency Use Permission to utilize its VitalPatch to identify variations in the QT interval of hospitalized patients under drug therapy for COVID-19.
Hydroxychloroquine and chloroquine used to manage some COVID-19 patients are correlated with the risk of QT interval prolongation, leading to life-threatening arrhythmias. VitalPatch permits clinicians to remotely and continuously manage patients at risk of QT prolongation due to COVID-19 medication.
According to the corporation records, it is the first biosensor able to monitor a broad set of patient vitals, which can be worn for up to 7-days and is powered by a disposable zinc-air battery for up to 168 hours of battery life. It measures 120 x 40 mm and is bound by a hydrocolloid adhesive to the patient.
COVID-19 presents a myriad of manifestations. Clinicians need access to medical tools that will allow them to control and manage symptoms in real-time and create appropriate treatment strategies for each need. The improvement of the Vital-Patch receiving Emergency Use Authorization for QT-interval detection will enable to support clinicians who are at the frontlines of treating this virus. (2,3)