Adherium Receives U.S. 510(k) Clearance for Over-the-Counter Sales of its Smartinhaler™ Sensor
27 Mar 2018
San Mateo, CA - March 27, 2018: 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.
The Smartinhaler sensor is a device installed onto a patient’s inhaler to monitor and promote asthma and COPD medication adherence as part of a self-management plan.
OTC clearance means that Adherium’s Smartinhahler SmartTouch for Symbicort® can now be sold directly to consumers in the U.S., including through pharmacies and online, without the need for the patient to first obtain a prescription.
“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.”
The next generation Smartinhaler sensor records the date and precise time the inhaler is used and automatically transmits this to an app on the patient’s phone or tablet. Smartinhaler technology stores the history of patient medication usage patterns, allowing physicians to review and help make evidence-based decisions. The sensor design includes three buttons that help patients easily access the audio visual-reminders, battery monitoring, and Bluetooth® wireless technology
Adherium’s 510(k) OTC clearance paves the way for the Company’s pending consumer launch and allows for greater support of AstraZeneca’s Symbicort in the U.S.
Adherium is a provider of digital health solutions and a global leader in connected respiratory medical devices, with over 100,000 distributed globally. The Company develops, manufactures and supplies patients, pharmaceutical companies, healthcare providers and contract research organizations with the broadest range of connected medical devices for respiratory medications. The devices and accompanying technology address sub-optimal medication use and strive to improve health outcomes in chronic disease. Adherium is headquartered in the USA, and operates globally from bases in the USA, Europe and Australasia. Learn more at adherium.com.
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