The device is intended to promote and improve bronchial drainage by using high-frequency oscillatory vibrations and intermittent negative pressure.
RT’s Three Key Takeaways:
- FDA Clearance for Simeox 200: Inogen Inc. has received FDA 510(k) clearance for the Simeox 200 airway clearance device, designed to enhance bronchial drainage and assist with the mobilization of bronchial secretions.
- Targeted Patient Population: The device is intended for patients with chronic lung diseases like bronchiectasis, COPD, cystic fibrosis, and primary ciliary dyskinesia, particularly those capable of independently generating a cough.
- Limited Launch Planned: Inogen plans a limited launch of the Simeox 200 in healthcare centers and homes in targeted sites starting in 2025.
Inogen Inc, a medical technology company offering respiratory products for use in the homecare setting, announced that it received US Food and Drug Administration (FDA) 510(k) clearance for the Simeox 200 airway clearance device.
Simeox 200 is the next generation of the original Simeox (currently available in select international markets). It is intended to promote and improve bronchial drainage by enhancing the mobilization of bronchial secretions via high-frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation.
The device is intended to be prescribed for use in patients capable of independently generating cough. Simeox 200 is predominantly aimed at helping patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as bronchiectasis, chronic obstructive pulmonary diseases, cystic fibrosis, or primary ciliary dyskinesia.
“We are very excited to receive FDA clearance for the innovative Simeox 200 therapy for patients in the US,” says Kevin Smith, president and chief executive officer, in a release. “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.”
Simeox 200 can be administered in healthcare centers and institutions, as well as at home.
Inogen plans to pursue a limited launch of Simeox 200 in targeted sites in 2025.
Photo caption: Simeox 200 airway clearance device
Photo credit: Inogen Inc
