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Adherium Receives Additional U.S. FDA 510(k) Clearance for U.S. Consumer Launch of the Hailie™ Solution
Jul. 27, 2018 09:33AM PST
Medical Device InvestingAdherium (ASX:ADR) has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter sales of its Hailie sensor. As quoted in the press release: Adherium’s Hailie sensor, previously known as Smartinhaler™, is a device that attaches to a patient’s asthma or COPD medication inhaler to monitor and promote adherence as …
Adherium (ASX:ADR) has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter sales of its Hailie sensor.
As quoted in the press release:
Adherium’s Hailie sensor, previously known as Smartinhaler™, is a device that attaches to a patient’s asthma or COPD medication inhaler to monitor and promote adherence as part of a self-management plan. This FDA clearance means access by consumers to Adherium’s Hailie online platform now expands from those using AstraZeneca’s SYMBICORT® (budesonide/formoterol fumarate dihydrate) to consumers using ProAir HFA, manufactured by Teva Pharmaceuticals, and Ventolin HFA and Flovent HFA, manufactured by GSK.
“This latest clearance kicks off our official entry into the U.S. consumer market, giving the tens of millions of US patients suffering from chronic respiratory conditions their own sidekick for asthma and COPD. Hailie is always there to support patients, helping them partner with their physicians to better manage and understand their condition,” said Arik Anderson, CEO of Adherium. “Clinically-proven monitoring and engagement, supported by 15 years of research and development, is on its way directly to patients in the U.S. through our e-Commerce portal at www.hailie.com.”
A wide body of clinical evidence supporting the benefits of the Hailie technology has been accumulated, including 74 peer-reviewed journal publications to date.
Adherium’s Hailie™ solution is designed to help patients achieve better adherence and provide visibility to parents and caregivers. It does this by tracking medication use and reminding the user with helpful nudges when it’s time to take doses, and by providing access to usage history to better understand patterns in their asthma and COPD. These tools ultimately enable people who live with asthma or COPD to more easily manage their condition alongside their physician.