We have just received the completed review on our newest ABPM model from the FDA. ABPM-06 has undergone premarket approval in which procedure its safety and effectiveness has been acknowledged by the U.S. Food & Drug Administration.
Even though the accuracy and reliability of our new ABPM has never been questioned, the approval of the FDA (as well as the long-standing CE certificate of the unit) allows our distributors all over the world to penetrate the market with ABPM-06. From an administrative point-of-view, this approval could decide whether we are welcome to enter specific markets, and, at the same time, it can serve as another proof of the unit’s quality.
The FDA approval can be checked at the agency’s website:
ABPM-06 has a lot to offer
The 6th generation of Meditech’s ambulatory blood pressure monitors entered the market in 2020, and since then we have experienced nothing but appreciation from our users regarding the quality of the unit. Now, that the device has been acknowledged in the U.S. as a medical equipment meeting all the necessary requirements, we are allowed to say that the unit represents the highest standard not only based on the users’ opinions, but also according to the most prestigious healthcare-related regulatory agencies as well. Besides the accuracy, ABPM-06 has a lot to offer including the inbuilt voice recording, the Meditech’s self-developed feature, the so called SleepWell® technology, manual programming option and many more user-friendly solutions.
Visit the page of ABPM-06 to learn more about this outstanding ABPM.
ABPM-06 - what else?
Actually, we have more to offer if you are specifically looking for an FDA-approved device. ABPM-06 has just joined the line of our ABPM Holters that has been approved by the U.S. agency.
ABPM-04 and ABPM-05 also meet the high standards required by the FDA. We are proud that the most important pillars of the Meditech ABPM product line are all worthy of having the approval of not only the domestic European market, but also the American authorities.