k-Nearest-Neighbor
July 1, 2022
Oncora Medical
August 1, 2022ClotChip Real-Time Coagulation Testing, Masimo Continuous RRp Monitoring & Abbott’s Freestyle Libre 2 Advanced Wearable Glucometer FDA Cleared
ClotChip Receives FDA Breakthrough Device Designation for Real-Time Coagulation Testing
The ClotChip device from XaTek incorporation has received FDA clearance as a handheld, point-of-care assay that can assess bleeding risk. Compared to traditional lab work, the principal advantage of the device is that it generates results in 15 minutes. This reduction in wait time is crucial for trauma patients and those suffering from bleeding disorders.
ClotChip device can evaluate a patient’s bleeding risk by employing a technique called dielectric spectroscopy, which quantitatively calculates how a blood sample affects an externally applied electric field. Also, it detects markers of coagulation activity in real-time and gives information about the clotting status of patients taking new-generation blood anticoagulants.
Masimo Receives FDA Approval for Continuous RRp Monitoring
Masimo is the leading brand of hospital pulse oximeters that provides accurate respiratory rate and oxygen saturation. The brand received FDA approval for its MightySat Rx, a fingertip pulse oximeter that can spot-check respiratory rate at home or hospital setting.
Checking respiration rate requires manually counting breaths with a timer or using chest straps. In contrast, the newly-approved Masimo RRp monitor permits health professionals to conveniently measure respiratory rate in patients whose oxygen saturation is already being monitored using the Masimo SETpulse oximetry monitor.
Respiratory rate is a determinant of a vital sign because breathing difficulty is considered one of the earliest signs of clinical deterioration. Thus, Masimo hopes that this recently FDA-approved device will play a crucial role in helping physicians as they treat respiratory-related diseases, including the coronavirus COVID-19.
Abbott's Freestyle Libre 2 Advanced Wearable Glucometer FDA Cleared
Abbott’s FreeStyle Libre 2 has received FDA approval for continuous glucose monitoring for adults and children with diabetes. The device delivers alarms on low and high glucose levels prompting patients to take action at the right time.
Glucose level measurement is achieved using a single sensor patch that works for two weeks straight and can take blood glucose readings as frequently as every minute. To download measurements and do spot testing, a smartphone-like reader is placed close to the sensor for about a second to make the automatic transfer of collected information. This is much more comfortable for patients compared to traditional finger stick tests.
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