Inogen Gets FDA 510(k) Clearance for SIMEOX 200 Device
Inogen, Inc. (Nasdaq: INGN), a medical technology company specializing in innovative respiratory products for homecare use, today announced it has received FDA 510(k) clearance for the SIMEOX 200 Airway Clearance Device. This approval enhances the company’s ability to market the device and address the diverse needs of patients with chronic respiratory diseases in the U.S.
This new device is designed to enhance bronchial drainage and improve the mobilization of bronchial secretions in patients with chronic respiratory conditions such as Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, and Primary Ciliary Dyskinesia. The SIMEOX 200 utilizes high-frequency oscillatory vibrations and intermittent negative pressure during exhalation to assist patients in clearing mucus from the lungs, providing a more effective treatment for mucus retention and hypersecretion.
SIMEOX 200 is intended for patients who are capable of independently generating a cough, making it an ideal solution for individuals with chronic lung diseases associated with excessive mucus production. The device has been designed to promote improved airway clearance, particularly in low lung volumes, allowing for efficient drainage of bronchial secretions. This makes SIMEOX 200 a suitable therapy both in healthcare settings and for home use, offering patients the flexibility to manage their conditions in a more convenient and effective manner compared to traditional airway clearance methods.
Kevin Smith, President and Chief Executive Officer of Inogen, expressed excitement about the FDA clearance, stating, “We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S. 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.”
Traditional airway clearance therapies often require significant time and effort from patients and healthcare providers, and results can be mixed. Many existing treatments can be inconvenient, especially for patients with chronic conditions who need consistent and effective care. In contrast, SIMEOX 200 offers a streamlined, efficient alternative that targets the specific needs of individuals suffering from mucus buildup and retention. The device is especially beneficial for patients with low lung volumes, providing an easier and more comfortable way to manage their condition at home.
The clearance of SIMEOX 200 by the FDA marks a significant milestone for Inogen, as it expands its product offerings to include this next-generation airway clearance device. The company plans to pursue a limited launch of the device in 2025, focusing on targeted sites to ensure that it can meet the needs of patients in healthcare institutions and at home. Over time, Inogen aims to significantly expand the availability of the SIMEOX 200, bringing the therapy to a larger patient population across the United States.
Inogen is committed to improving patient outcomes by developing and providing best-in-class respiratory therapy products. The company works closely with healthcare providers, home medical equipment suppliers, distributors, and patients to ensure that its products are widely available and effective in treating a range of chronic respiratory conditions. By incorporating the SIMEOX 200 into its portfolio, Inogen is continuing its mission to help patients manage their diseases more effectively and improve their quality of life.
As a leader in the respiratory therapy field, Inogen remains focused on bringing innovative solutions to the market. With its proven track record of developing cutting-edge medical technologies, Inogen is poised to make a significant impact in the airway clearance space, particularly with the introduction of SIMEOX 200. This new device provides patients with a more efficient and convenient way to address the challenges of mucus retention and hypersecretion, paving the way for better management of chronic respiratory diseases in both healthcare settings and at home.
About Inogen
Inogen, Inc. (Nasdaq: INGN) is a leading global medical technology company focused on providing innovative respiratory products for use in the homecare setting. Inogen develops, manufactures, and markets a range of respiratory therapy devices that deliver effective care to patients suffering from chronic respiratory conditions. By partnering with healthcare providers, prescribers, home medical equipment providers, and distributors, Inogen ensures that its respiratory therapy products are widely available, allowing patients to better manage their chronic conditions and improve their overall quality of life. With the introduction of the SIMEOX 200, Inogen continues to expand its portfolio of groundbreaking respiratory solutions.
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