FDA Clears Smartphone-Connected Inhaler from Nexus6

New Zealand-based medical device company Nexus6 has received U.S. Food and Drug Administration (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 personal computer. As the device’s name suggests, it sports a tiny, touch screen display too.

“Nexus6 was established in 2001 and has been developing Smartinhaler technology ever since,” Nexus6 CEO Garth Sutherland said in a statement. “The SmartTouch is the latest generation in Nexus6’s Smartinhaler [line of devices]. The SmartTouch supersedes our SmartTrack device, which is proven in clinical trials to double preventative medication adherence levels.” 

Nexus6 submitted its device to the FDA for approval in December.

There is a growing number of smart inhalers in the market today, the the total still remains relatively small. Perhaps the best known is Propeller Health, which uses GPS-connected inhalers to collect data about the time and place of patients’ 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 chronic obstructive pulmonary disease (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  automatically is 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 firm 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 said 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, Mass.-based GeckoCap makes smart inhaler caps to track childrens’ adherence. The company sells its product directly to consumers.