San Diego, California-based ResMed has received FDA 510(k) clearance for its small, portable continuous positive airway pressure (CPAP) device, the AirMini. The announcement was made during the JP Morgan conference in San Francisco today.
Designed to be used as an secondary device – particularly during travel or any other time the user doesn’t have access to or doesn’t want to bring their full-size CPAP device along – the AirMini is ResMed’s first FDA approval and will be launched later this year. The device, which is not yet commercially available, comes in a case about the same size as one used to carry sunglasses.
“This is something that you take with you, you go through the TSA line with it, and when you get to where you are going, you just pull it out of your bag like you would your smartphone and plug it in,” ResMed CEO Mick Farrell told MobiHealthNews in an interview. “It’s a way to take treatment for sleep apnea mainstream, which is needed because it is so common.”
Farrell cited estimates of about 60 million people in the United States who have sleep apnea, but many are undiagnosed, or do not seek treatment at all.
“Eighty percent of people with sleep apnea are not currently on any breathing therapy, because a lot of the devices are hard to use, they are noisy, they are disruptive to both the user and their partner,” Farrell said. “For someone who travels a lot, it gets even more difficult.”
So that’s where ResMed is positioning the AirMini, Farrell said.
“It’s going to be a different experience for travelers, where sleep is especially important,” he said, adding that the current research and technology environment is ripe for sleep innovation. “Sleep is taking off. Clinical research is catching up to the digital space.”
The AirMini also works with ResMed’s app myAir, which the company launched in August. It gives users of ResMed’s connected CPAP devices contextual information-based coaching on how to improve their therapy through videos, emails and encouragement along the way. In a retrospective study with Kaiser Permanente, researchers found people are more likely to be adherent to CPAP therapy when they get feedback from connected devices and apps. In general, CPAP compliance is 60 percent, but patients who use the myAir get it up to 84 percent, which is attributable to the feedback loop patients get from the connected device.
ResMed launched its CPAP bedside devices, Air Solutions, in 2014. All devices (AirSense and AirCurve) contain cellular chips that store and transmit data. The program was originally launched as a website shortly after the 2014 device launch. Core customers are home healthcare providers, but the company also work with physicians. ResMed has a dedicated team and program called the ResMed Data Exchange that integrates with EHRs.
Last week, ResMed also announced SleepScore Labs, their joint venture with Dr. Mehmet Oz and Pegasus Capital Advisors that aims to compile and analyze consumer sleep data. Dr. Oz, a cardiac surgeon and well-known television personality, said he was attracted to ResMed because of the company’s sleep monitoring technology S+, which consists of a non-contact bedside sleep monitor and companion app.
"The statistics on sleep disorders are staggering," Oz said in a statement. "More than 70 million Americans suffer from a sleep disorder. Drowsy driving is responsible for thousands of fatal crashes a year. The list goes on and on. ResMed has the technology to help us measure, understand and educate people who are struggling with sleep. We know if people have the right tools, they will be able to improve their sleep and overall health.”