News

PulmOne recently received two additional regulatory approvals for the sale of the MiniBox+. The MiniBox+ now holds the Health Canada License, and is also certified by TGA Australia. These approvals were obtained only four months after the MiniBox+ received FDA clearance, in October 2016.

PulmOne Advanced Medical Devices is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the MiniBox+ device for sale in the USA. In addition to all the parameters measured by the MiniBox, the MiniBox+ has an integrated module for single breath Carbon Monoxide Diffusing Capacity (DLCO) testing. It offers fully automated measurements of Calculated DLCO, VA, and KCO.

With this clearance, PulmOne now offers complete pulmonary function testing in any clinical setting.

PulmOne participated in a number of exhibitions at scientific conferences both in Europe and the US in recent weeks. Visitors to our booth observed live MiniBox demonstrations of lung volume measurements with only 2 minutes of tidal breathing, and were impressed with the ease of use, automatic measurements, and portability of the device.