Just over a week after receiving 510(k) clearance for a Hailie inhaler sensor for use with Ellipta DPIs, Adherium said that it filed a 510(k) submission to the FDA for a new Hailie sensor to be used with GSK’s Ventolin, Advair, and Flovent MDIs. The new Hailie sensor measures various parameters, including respiratory flow rate, and connects to the company’s Hailie remote patient management platform .
Adherium VP of Quality, Regulatory and Clinical Affairs Tara Creaven-Capasso said, “Submitting this market application marks another development milestone towards our vision of enabling healthcare providers to enhance patient care by capturing clinical data and supporting patient management. Following the recent 510(k) market clearance of GSK’s Ellipta inhaler, designed for use with Breo, Anoro, Incruse, Trelegy and Arnuity, this 510(k) submission marks, once again, execution on our strategy and delivering on our product roadmap milestones.”
Creaven-Capasso added, “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. We recognize the importance of integrating technology into patient care and one of the challenges healthcare providers are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. With the US Centers for Medicare and Medicaid Services (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.
