Mallya is coming to America. The U.S. Food and Drug Administration (FDA) recently granted clearance to the smart medical device from the French manufacturer Biocorp. First launched in French pharmacies in spring 2021, Mallya is an add-on that fits atop a range of disposable insulin pens to transmit injection data via Bluetooth to companion software in real time. According to its makers, Mallya is the first system approved for use in the United States that can automatically connect different kinds of insulin and GLP-1 medications that lower blood glucose levels.

So what exactly does Mallya do? The device attaches directly to insulin pen injectors to track each injection, recording the dosage and the type of insulin, as well as the time and date of the injection. Mallya is compatible with most disposable insulin pens (Biocorp says 91% of those on the market), including Solostar, Kwikpen, and Flexpen. Data transfers automatically to a smartphone, where the Mallya app — which can connect to two Mallya devices — stores the user’s last 100 insulin deliveries. The saved report can then be shared with healthcare professionals. Usable for up to two years, Mallya recharges with a USB port, needing a charge about once a month.

If you go by ads on TV, you might think that the United States leads the world in its use of disposable insulin pens. However, the U.S. lags behind other parts of the planet in this area: a recent paper found that around 59% of patients with diabetes use insulin pens in America, compared with around 94% in Europe. This high level of insulin pen use around the world is not surprising given the global prevalence of diabetes; according to the International Diabetes Federation (IDF), more than 537 million people on the planet have diabetes mellitus (DM), and somewhere between 150 to 200 million of these people use insulin to treat the disorder.

While smart pen technology may seem commonplace today, it was quite novel not so long ago. In 2017, InPen was the first smart insulin pen to land FDA clearance, and InPen only gained the ability to generate reports on missed doses and the level of insulin left in the pen in 2020. Biocorp CEO Eric Dessertenne says of Mallya’s entrance into the U.S. market, “This approval marks a historic achievement for Biocorp as it allows the commercial launch of our Mallya device in the United States and illustrates Biocorp’s ability to meet the highest regulatory requirements…we are delighted that U.S. patients will soon be able to benefit from Mallya’s services.”