Adherium has submitted a 510(k) application for use of its next generation Hailie inhaler monitoring sensor with Teva’s ProAir albuterol MDI and its generic albuterol HFA MDI, the company said. Recently, the company filed a 510(k) submission for use of the Hailie sensor with GSK’s Ventolin, Advair, and Flovent MDIs, and the FDA cleared the Hailie sensor for use with Ellipta dry powder inhalers. The next generation Hailie sensor was previously cleared for use with the Symbicort MDI in September 2021.
Adherium VP of Quality, Regulatory, and Clinical Affairs Tara Creaven-Capasso commented, “Hailie is a clinically proven chronic respiratory management solution and is the only 510(k) cleared digital sensor available today to offer physiological data insights for inhaler technique. Submitting another 510(k) application to the US FDA represents a key milestone for the company as we continue to execute on our market expansion strategy to extend our digital product portfolio.”
Creaven-Capasso added, “The 510(k) submission is the first step in the review process with the FDA, and we look forward to working with the Agency to obtain market clearance. The addition of Teva ProAir and Teva albuterol sulfate HFA to the Hailie range of products will broaden the pathway for Adherium’s customers in the US to access reimbursement for remote monitoring of patients prescribed asthma and COPD medications.”
Read the Adherium press release.
