Hogan Lovells leads NONAGON to FDA 510(k) clearance for smartphone compatible telehealth device

NONAGON is a handheld device that pairs with a smartphone to remotely conduct the most common measurements performed in a doctor’s office. With the N9 device, users can take measurements at home with a stethoscope, otoscope, pulse oximeter, and thermometer. In addition, by using the smartphone camera photographs of the mouth and throat or skin lesions can be taken. The device transmits that data to the user’s doctor to aid in telehealth examinations. The device has been cleared for use in patients aged 2 years and older, making it suitable for a broad range of primary, chronic, and urgent care modalities for all demographics from pediatrics to seniors. Telehealth devices have become even more important for the remote treatment of patients during the pandemic.

Hogan Lovells assisted NONAGON with all stages of FDA regulation, starting with formulating regulatory strategy, shepherding the company through the pre-submission process, drafting and submitting the marketing application, and resolving the Agency’s multiple requests for additional information.

The Hogan Lovells regulatory team included partners Jonathan Kahan, Kristin Zielinski Duggan, and Lina Kontos, as well as Director of Regulatory Sciences Michael Kasser.

More information can be found on NONAGON's press release here.