Insulcloud, a diabetes management-focused healthtech company, has received the US Food and Drug Administration (FDA) clearance for its Insulclock CAP smart device.
Insulclock CAP is designed to track the use of disposable insulin pens in real time. It aims to improve patient adherence to prescribed therapy.
The clearance will allow Spain-based Insulcloud to commercialise its proprietary diabetes management solution in the US market.
According to the healthtech company, the device will empower American diabetes patients to manage their insulin therapy more precisely and confidently.
The Insulclock CAP turns disposable insulin pens into advanced diabetes management tools. This Bluetooth-enabled device offers visual and audible alerts to help users optimize their insulin therapy.
It promotes safe and effective use of insulin pens. The Insulclock CAP captures essential data, including insulin brand, dose, injection date and time, and the pen’s temperature during injection.
In addition, the diabetes care technology automatically distinguishes between bolus and priming insulin.
Insulcloud general manager Judith Ruiz de Esquide said: “We understand the challenges faced by individuals living with diabetes, and we are committed to improving their quality of life.
“Our outperforming smart pen cap not only empowers patients to manage their condition more effectively, but also helps reduce costs for insurance providers by minimising complications and hospitalisations.”
The Insulclock CAP is designed for patients with type I or type II diabetes mellitus using disposable insulin pens. Insulcloud said the device is compatible with all insulin brands.
This diabetes care solution, paired with a companion app, is already in use across Europe, with thousands of daily users.
Furthermore, Insulclock integrates with existing healthcare apps via an FDA-cleared software development kit (SDK).
The diabetes management company is also seeking distribution partners for the US market and is considering opening its first international office in Boston.
Insulcloud offers a suite of diabetes-related products, including the Insulclock CAP and the 360º Digital HEALTHCARE Solution for providers.
The company has raised over $14m in venture funding to date. Its strategic partners include Dexcom, IBM, and Ascensia Diabetes Care.
Last month, Insulcloud, a Barcelona Health Hub (BHH) member, announced FDA clearance to market the Insulclock Pro device in the US.
