Donawa Lifescience helps Tournicare achieve US marketing clearance for ARMA OTC BPM

The Australian start-up company Tournicare Pty Ltd has achieved US marketing clearance from the Food and Drug Administration (FDA) for its ARMA over-the-counter Blood Pressure Monitor (BPM) via the 510(k) pre-market notification process with regulatory assistance from Donawa Lifescience. Tournicare announced its success in a LinkedIn post in mid-June.

Tournicare CEO Niels van Sparrentak explains: “Self-assessment of BP in the home environment using existing devices often requires assistance, the devices are difficult to use and are not designed with the end-user in mind. Because of this, it is estimated that 1 in 3 people measure their BP incorrectly at home.”

Tournicare’s innovative solution provides accuracy through ease-of-use. Delivered in a compact, modern and patient-friendly design, ARMA is able to be secured single-handedly in the correct position on the upper arm by means of an automatic clamping mechanism, thus avoiding the use of Velcro straps.

Donawa Lifescience has been working with Tournicare since 2021, when the ARMA technology was in its infancy, initially by assisting with a Pre-Sub to the FDA, followed by a number of follow-up supplements, leading eventually to the successful 510(k) submission.

Donawa Lifescience congratulates Tournicare on achieving this marketing clearance for the US market and trusts that further innovative medical devices will follow from this young company.