Breathe Technologies, a developer and manufacturer of innovative medical technologies for patients with respiratory insufficiency diseases and neuromuscular diseases, announced that it received CE Certification for its Non-Invasive Open Ventilation (NIOV) System, enabling the company to market and sell the device in the European Union.
In addition, the NIOV System has been recognized by the European Respiratory Society with its Product of Outstanding Interest (POINT) Award for 2014.
The Breathe NIOV System is the first and only wearable, ventilation system for people with respiratory insufficiency to receive a CE Mark.
The Breathe NIOV System provides augmented tidal volume, which reduces the work of breathing for people with respiratory insufficiency caused by chronic obstructive pulmonary disease (COPD), including Alpha-1 Antitrypsin Deficiency.
When Breathe Technologies received its first U.S. FDA 501(k) Clearance in 2010 for the NIOV System, it was the first innovation in the ventilation category since 1998. Medical devices must be CE marked before they can be legally used in Europe.
The Breathe NIOV System was certified under the European CE Full Quality Assurance System Directive 93/42/EEC for Medical Devices, Annex II excluding (4). The review was carried out by AMTAC Certification Services Limited, Milton Keynes, UK, which authorized Breathe Technologies to use the CE 0473 mark for its NIOV System.
"Receiving a CE Mark for our NIOV System is a significant milestone for Breathe Technologies and we appreciate the concurrent recognition from the European Respiratory Society," said Larry Mastrovich, president and CEO, Breathe Technologies. "We are now exploring potential commercialization partners for the EU and developing a European advisory board."