Product
Medical
Clinical Validation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
It is of great importance to have products evaluated and validated in accordance with protocols set by organizations such as the British Hypertension Society (BHS), the Association for the Advancement of Medical Instrumentation (AAMI) and, the Working Group on Blood Pressure Monitoring of the European Society of Hypertension (ESH). The protocols of these organizations have become highly regarded standards. In the US, our products meet FDA requirements, facility audits, and regulatory pathways via the 510(k) process. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
In light of the fact that our Blood Pressure Monitors are to be absolutely dependable, many of our blood pressure devices have been validated early in their life cycle. It has become imperative to have the Ambulatory Blood Pressure Monitors (ABPM) evaluated by physicians to verify their accuracy for use in the clinical setting. . Our ABPM has gone through a considerable number of evaluations by prominent physicians to further advance accuracy and reliability. The TM-2420 (ABPM) became the standard of its day, while the newer and current version, the TM-2430, has become the new standard. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
In recent years, physicians have come to see the value of monitoring blood pressure at home to compliment treatment of their hypertensive patients. They regard devices for home use accurate enough to support their patients continuing care. Consequently, the demand for device validation of personal monitors has increased. At A&D, as leaders in blood pressure technology we are confident in the accuracy of our devices and the ability to be able to fulfill the strict requirements of healthcare professionals. All of our blood pressure monitors are validated independently in order that they comply with varying governmental regulations. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
A majority of our monitors have also been validated by leading professionals. UA-767 and UA-767 Plus were validated and published in accordance with the BHS protocol. Others like UA-631/779 or UA-787 were validated under the new ESH protocol. Both have received notoriety for their publications in the professional journals like Blood Pressure Monitoring. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
These examples demonstrate the performance of our products. Others studies are under development, which shall subject our devices to stringent testing and evaluation in order to create products that professionals can use with confidence. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The list of our monitors validated under world-class protocols | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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