ResMed wins FDA nod for AirMini CPAP device

ResMed (NYSE:RMD) said today it won FDA 510(k) clearance for its AirMini continuous positive airway pressure device. The San Diego, Calif.-based company touted the AirMini as the world’s smallest CPAP device, and said it plans to launch it later this year. ResMed said the AirMini is designed as a secondary CPAP device, designed to allow patients to maintain sleep apnea therapy while traveling. “ResMed AirMini is the portable travel CPAP patients and home medical equipment providers have been waiting for, and we look forward to bringing it to market later this year. It fits easily in carry-on luggage – even in the seatback pocket on the plane–and delivers all the best-in-class comfort features patients need to get the best sleep,” CEO Mick Farrell said in prepared remarks. Last month, a German court overturned preliminary injunctions granted to ResMed in a patent infringement case filed in August by Fisher & Paykel Healthcare (NZE:FPH). With the overturned injunction, Fisher & Paykel said it has resumed sales of its Simplus full face mask, Eson nasal mask and Eson 2, which ResMed claimed infringed on its patents. Fisher & Paykel initiated the hostilities with an August 15 lawsuit in a California federal court, alleging that ResMed’s AirSense 10 and AirCurve 10 flow generators, ClimateLineAir heated air tubing and Swift mask line infringe 11 of its patents. The Auckland, N.Z.-based company moved to withdraw that suit the next day, b...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Respiratory ResMed Inc. Source Type: news