Eko
January 1, 2023
Microfluidic Smartphone Dongle Detects COVID-19
February 1, 2023FDA Updates
At-Home Clinical ECG
The COVID-19 pandemic has changed many, if not all, medical fields as we know them; for the most part, patients are advised to refrain from visiting hospitals and clinics, if possible, to reduce the risk of transmission of this infection. Visits and procedures are conducted over video calls from home; this is also true for medical devices.(1)
Heart disease is a significant cause of morbidity worldwide; this population is at an increased risk for complications of COVID-19. Heart monitors are a vital component in the management of these patients. Accessing a clinical-grade electrocardiogram (ECG) became an issue because it involves scheduling an office visit. This risk was required from patients since consumer devices do not satisfy the comprehensive and professional level ECG evaluation needed for making a more assertive diagnosis that cardiologists provide.(1)
An LA-based firm called QT Medical developed the “PCA 500 system,” a novel option that enables patients to perform a thorough medical-grade ECG at home compared to one done at the hospital but with the benefit of avoiding exposure to COVID-19. This system automatically sends the data to the doctor’s office for close review. This development is complemented by an “Xpress ECG service” that allows doctors to prescribe the 12-lead ECG and have the patients receive this machine in just a few days by mail.(1)
The COVID-19 pandemic has changed many, if not all, medical fields as we know them; for the most part, patients are advised to refrain from visiting hospitals and clinics, if possible, to reduce the risk of transmission of this infection. Visits and procedures are conducted over video calls from home; this is also true for medical devices.(1)
Heart disease is a significant cause of morbidity worldwide; this population is at an increased risk for complications of COVID-19. Heart monitors are a vital component in the management of these patients. Accessing a clinical-grade electrocardiogram (ECG) became an issue because it involves scheduling an office visit. This risk was required from patients since consumer devices do not satisfy the comprehensive and professional level ECG evaluation needed for making a more assertive diagnosis that cardiologists provide.(1)
An LA-based firm called QT Medical developed the “PCA 500 system,” a novel option that enables patients to perform a thorough medical-grade ECG at home compared to one done at the hospital but with the benefit of avoiding exposure to COVID-19. This system automatically sends the data to the doctor’s office for close review. This development is complemented by an “Xpress ECG service” that allows doctors to prescribe the 12-lead ECG and have the patients receive this machine in just a few days by mail.(1)
First Dedicated Pediatric and Neonatal Acute Dialysis Machine Released US
Carpediem, according to the oxford dictionary, is defined as “making the most out of the present time.” It is also the first device in the United States designed for pediatric and neonatal acute dialysis. The Carpediem (Cardio-Renal Pediatric Dialysis Emergency Machine) is a very clever and descriptive acronym chosen by Medtronic, the device’s developer. Generating this device took about ten years and six years to win FDA marketing approval after the first human use in 2014. After about ten years of constructing this device and six years after the first human use; distribution has started and is now available to hospitals nationwide. Cincinnati Children’s Hospital Medical Center has these machines up and running.
Conventional dialysis machines are designed for adult use. Yet, they are used off-label in children and neonates as many medical and surgical cardiac and kidney conditions can lead to the need for continuous renal replacement therapy (CRRT). With the arrival of Medtronic’s Carpediem, some of the limitations and risks associated with using conventional dialysis machines are overcome. This FDA-cleared device has established specific indications, including acute kidney injury, fluid overload, and the need for hemodialysis or hemofiltration therapy in patients whose weight ranges between 2.5-10 Kg. leo.(2)
Carpediem, according to the oxford dictionary, is defined as “making the most out of the present time.” It is also the first device in the United States designed for pediatric and neonatal acute dialysis. The Carpediem (Cardio-Renal Pediatric Dialysis Emergency Machine) is a very clever and descriptive acronym chosen by Medtronic, the device’s developer. Generating this device took about ten years and six years to win FDA marketing approval after the first human use in 2014. After about ten years of constructing this device and six years after the first human use; distribution has started and is now available to hospitals nationwide. Cincinnati Children’s Hospital Medical Center has these machines up and running.
Conventional dialysis machines are designed for adult use. Yet, they are used off-label in children and neonates as many medical and surgical cardiac and kidney conditions can lead to the need for continuous renal replacement therapy (CRRT). With the arrival of Medtronic’s Carpediem, some of the limitations and risks associated with using conventional dialysis machines are overcome. This FDA-cleared device has established specific indications, including acute kidney injury, fluid overload, and the need for hemodialysis or hemofiltration therapy in patients whose weight ranges between 2.5-10 Kg. leo.(2)
