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medical device investing

Adherium Receives U.S. 510(k) Clearance for Over-the-Counter Sales of its Smartinhaler Sensor

Written by Gabrielle Lakusta
|
Mar. 27, 2018 08:59AM PST

Adherium (ASX:ADR), a digital health company that improves medication adherence and patient outcomes, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter (OTC) sales of its SmartinhalerTM sensor for AstraZeneca’s Symbicort® aerosol asthma inhaler. As quoted in the press release: “Over-the-counter sales of our Smartinhaler sensor for the Symbicort aerosol …

Adherium (ASX:ADR), a digital health company that improves medication adherence and patient outcomes, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter (OTC) sales of its SmartinhalerTM sensor for AstraZeneca’s Symbicort® aerosol asthma inhaler.

As quoted in the press release:

“Over-the-counter sales of our Smartinhaler sensor for the Symbicort aerosol inhaler continues the advance of our vision for stronger partnerships between patients and physicians by making adherence to personal management plans easier,” said Arik Anderson, CEO of Adherium. “We are now well positioned to launch in the U.S., following successes in Europe and Australia. We are providing clinically-proven monitoring to support patients in adopting their physicians’ guidance into their daily lives, and so close the gap between science and real-world care.”

Click here to read the full press release.

europe australia over the counter medical device investing food and drug administration
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