Inogen, a US-based medical technology company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its SIMEOX 200 airway clearance device.
The SIMEOX 200 is the latest version of the Simeox, a bronchial drainage device developed by France-based respiratory care solutions provider Physio-Assist.
Last year, Inogen acquired Physio-Assist, including the Simeox device, which has been granted CE mark approval in the EU and is sold in Europe, Asia, and the Middle East.
The SIMEOX 200 device is designed to promote bronchial drainage by enhancing the mobilisation of bronchial secretions.
It uses high-frequency oscillatory vibrations and intermittent negative pressure during exhalation.
The device is intended for patients capable of independently generating a cough and is primarily aimed at those with chronic lung diseases.
Chronic lung diseases include bronchiectasis, chronic obstructive pulmonary diseases (COPD), cystic fibrosis, and primary ciliary dyskinesia.
Inogen president and CEO Kevin Smith said: “We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the US.
“By tapping into our well-established network of healthcare providers, B2B partners, and our Direct-to-Patient team, we aim to bring this next-generation airway clearance device to patients within the next year and significantly expand our reach over time.”
According to the company, traditional airway clearance therapies can be time-consuming and yield mixed results.
SIMEOX 200 provides an alternative for effective bronchial drainage, especially in low lung volumes, and can be used in healthcare centres and institutions, along with home settings.
Inogen said the FDA approval allows the commercialisation of the device in the US and is planning a limited launch of SIMEOX 200 in targeted sites in 2025.
