According to Adherium, the FDA has granted 510(k) clearance for OTC sales of the company’s Hailie adherence monitoring sensor for use with several MDIs for the treatment of asthma.
In March 2018, the FDA granted 510(k) clearance for OTC sales of the sensor for use with Symbicort; the new clearance covers use with ProAir HFA, Ventolin HFA, and Flovent HFA. The sensor, formerly known as “Smartinhaler,” was rebranded as “Hailie” in May 2018.
The sensor and a subscription plan for use of the Hailie monitoring platform will be sold directly to patients through a web site. Currently, the pricing listed on the web site for the Symbicort version is $99.50 for the sensor and $5.95/month or $59.50/year for the subscription.
The company said that healthcare providers will be have access to patient-group data collection and reports from Hailie sensors through a new online portal.
Adherium CEO Arik Anderson said, “This latest clearance kicks off our official entry into the US 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.”
Read the Adherium press release.
