Microsoft
June 1, 2022
Gastroenterology
June 1, 2022World’s First 6-Lead Consumer ECG; First Device for Predicting Risk of Pressure Ulcers; FDA Cleared FDA Clears Geko Muscle Pump Activator
AliveCor Introduces World’s First 6-Lead Consumer ECG, the KardiaMobile 6L
AliveCor is a company that introduced reliable and helpful ECG monitoring to consumers. Their products, which operate as virtual single-lead ECG devices, have been cleared by the FDA to detect cardiac arrhythmias.
Single lead ECGs are simple, as the user only needs to hold onto a device with both hands, creating a one-lead circuit. For that reason, AliveCor is now introducing a newly FDA-cleared six-lead ECG that does not have any wires.
During an ECG recording with KardiaMobile 6L, the user puts fingers on the pair of electrodes on one side, and the third electrode touches the skin around the ankle. As a result, this creates the necessary circuit to provide the I, II, III, aVL, aVR, and aVF ECG leads.(1)
First Device
for Predicting Risk of Pressure Ulcers FDA Cleared
Pressure ulcers are a common complication for patients confined to bed by sickness or old age, which is a situation that most health professionals have been battling to improve. For this reason, Bruin Biometrics, a company based in California, landed FDA clearance for the first device that objectively evaluates a patient’s propensity for developing a pressure ulcer in a given part of the body.
This predisposition is evaluated using an SEM Scanner wireless handheld device that detects localized edema and tissue fluid-related inflammation in the sub-epidermal layer days before visual skin damage. This information provides anatomically specific risk advice for nurses and clinicians to institute additional preventive treatment for patients’ unique needs.(2)
FDA Clears Geko Muscle Pump Activator to Prevent VTE
Venous thromboembolism (VTE) is a severe and common complication of patients confined to bed, and this is one reason patients are encouraged to mobilize as soon as they can. Since VTE is a usual and significant medical problem, the FDA has cleared Geko from Sky Medical Technology to prevent this condition.
Geko works as an inflatable wrap placed around the legs that stimulates the common peroneal nerve, thus creating adequate timed contractions to the calf muscles, increasing blood circulation, and helping to prevent VTE. The device was previously approved to be used immediately after surgeries. However, this muscle pump activator is now accessible for health professionals to use on all patients at risk of VTE.(3)
