US-based MedInvent has obtained CE Marking and ISO 13485 and CMDCAS certification for its NasoNeb II nasal nebulizer, the company said. The company has also signed a distribution contract with Vedise Hospital in Rome, Italy, which will market the product in Italy, San Marino, and Vatican City.
MedInvent says that it plans to market the nasal nebulizer throughout the EU and will apply for approval to market the device in additional countries. The NasoNeb II has been available through a number of pharmacies in the US since 2009.
MedInvent Managing Partner William Flickinger commented, “We look forward to working with European physicians treating patients who suffer with sinus conditions. In particular, for those people who have not responded to therapy in the way their physicians would have expected, despite their physician’s best efforts, the NasoNeb System represents a promising new delivery method to ensure that a high concentration of medication is delivered throughout the nasal and paranasal sinus cavities.”
Read the MedInvent press release.