Adherium announced that the FDA has granted 510(k) clearance for use of Adherium’s next-generation Hailie inhaler sensor with GSK’s Ventolin, Advair, and Flovent MDIs. The company had announced submission of the 510(k) application in August 2022.
Adherium CEO Rick Legleiter said, “This is the third 510(k) market clearance of the next-generation Hailie sensors capturing physiological data, following the Hailie sensors for AstraZeneca’s Symbicort pMDI inhaler and GSK’s Ellipta dry powder inhalers enabling even more medication coverage for US remote patient monitoring reimbursement. Achieving these significant milestones for the company, we continue to broaden our regulatory footprint to be the drug agnostic, global digital partner of choice on our path toward building a sustainable, cash flow positive business.”
VP of Quality, Regulatory and Clinical Affairs Tara Creaven-Capasso commented, “Our objective with each generation of the Hailie sensor is the pursuit of our mission – to be the leading digital solution for remote patient monitoring; integrating devices and data to optimize outcomes for patients, healthcare professionals and payers. With CMS focused on providing new and expanded reimbursement options for virtual care management programs, more reimbursement opportunities for doctors are available, which gives access to comprehensive patient data for more effective care delivery, better care coordination, and improved health outcomes.”
Read the Adherium press release.
