2021
Jul
20
新聞
HCmed Receives FDA 510(k) Approval for Pulmogine
HCmed Innovations is delighted to announce that it has received US Food and Drug Administration (FDA) 510(k) clearance for its portable mesh nebulizer, Pulmogine. Pulmogine Vibrating Mesh Nebulizer has been designed to deliver inhaled medications directly into the airways, aiming to provide patients relief from the discomfort of respiratory diseases.
Besides clearance from the US FDA, Pulmogine has also obtained CE marking and approvals from multiple international health authorities, such as Taiwan’s TFDA, Brazilian Anvisa, Indonesian Badan POM, and China’s NMPA.
The technology developed by HCmed enables Pulmogine to turn liquid medication into very fine aerosol particles, which can be delivered deeply into the lungs. Moreover, its portability and easy-to-use features allow patients to receive inhalation treatment conveniently.
HCmed’s nebulizers are currently available in Brazil and China. With the obtention of the 510(k) clearance, HCmed looks forward to helping more patients who may suffer from different types of respiratory diseases as Pulmogine enters a new market.
Besides clearance from the US FDA, Pulmogine has also obtained CE marking and approvals from multiple international health authorities, such as Taiwan’s TFDA, Brazilian Anvisa, Indonesian Badan POM, and China’s NMPA.
The technology developed by HCmed enables Pulmogine to turn liquid medication into very fine aerosol particles, which can be delivered deeply into the lungs. Moreover, its portability and easy-to-use features allow patients to receive inhalation treatment conveniently.
HCmed’s nebulizers are currently available in Brazil and China. With the obtention of the 510(k) clearance, HCmed looks forward to helping more patients who may suffer from different types of respiratory diseases as Pulmogine enters a new market.