New Zealand-based medical device company Nexus6 has received FDA clearance for its smartphone-connected inhaler, SmartTouch, as a class II medical device. The new SmartTouch device has been cleared as a prescribable Metered Dose Inhaler (MDI) with a handful of intended uses: in clinical trials; in clinical practice, and for patient self-management.
In all cases the device is used to help track usage, but it does not sense or report on the remaining amount of medication in the device and it does not offer a dose counting feature. The SmartTouch inhaler records the date and time the inhaler is used, which is then both stored on the device itself and transmitted wirelessly to the patient's smartphone, tablet, or PC. As the device's name suggests, it sports a tiny, touch screen display too.
“Nexus6 was established in 2001 and has been dedicated to developing Smartinhaler technology ever since," Garth Sutherland, Chief Executive Officer of Nexus6 said in a statement. "The SmartTouch is the latest generation in Nexus6’s Smartinhaler [line of devices]. With each new generation our Smartinhalers get smaller, easier to use, and incorporate more sensors that generate higher quality data, and higher levels of medication adherence. The SmartTouch supersedes our SmartTrack device, which is proven in clinical trials to double preventative medication adherence levels.”
While the company just announced the clearance this week, Nexus6 submitted its device to the FDA in December and the clearance went through in April.
While there aren't many, there is a growing number of smart inhalers in the market today. Perhaps the best known is Propeller Health, which uses GPS-connected inhalers to collect data about where and when patients have attacks. In May Propeller, formerly Asthmapolis, received FDA clearance for a new iteration of its platform that includes a new smart inhaler and is geared for patients with either asthma or COPD.
The new platform helps users to prevent so-called “asthma attacks” or similar lung inflammation symptoms caused by COPD. The Propeller Metered-Dose Inhaler, which is Bluetooth Low Energy-enabled, measures a patient’s use of their rescue inhaler. That data is automatically compared to a patient’s baseline and to general clinical guidelines, and the app can alert care teams if an attack seems likely. In addition to its previously existing coaching program focused on how to manage the disease, recognize symptoms and avoid triggers, the system will now be able to coach users on how to use their inhaler properly.
In April Biopharmaceutical company Opko Health acquired Israeli smart inhaler company Inspiro Medical for a sum in “the low eight figures”, Opko’s Director of Strategic Investment Les Funtleyder told MobiHealthNews at the time. The company will be using Inspiro’s Inspiromatic technology to develop an app-connected inhaler that will be bundled with a forthcoming new drug for asthma, COPD, and cystic fibrosis.
The Inspiro inhaler has features that make it easier to use, including an active powder de-agglomerator to ease inhalation and a microcontroller that better times the delivery of inhaled drugs. A connected app could be used to give near realtime feedback and instruction on proper use of the inhaler as well as to access data from sensors contained in the inhaler and to send that data to physicians, caretakers, or parents. The inhaler performed better than the gold standard in a small trial last year, according to the company.
Finally, Cambridge, Massachusetts-based GeckoCap makes smart inhaler caps to track kids' adherence. The company sells its product direct to consumer.