Insulcloud wins FDA nod to bring smart insulin pen cap tech to U.S.

October 29, 2024 By Sean Whooley

Madrid, Spain-based Insulcloud designed the device to monitor patient use of disposable insulin pens in real-time, increasing therapy adherence. The company said in a news release that the U.S. expansion underscores Insulclock CAP’s safety, efficacy and quality.

Insulclock CAP, a Bluetooth-enabled medical device, helps transform disposable insulin pens into tech-enabled diabetes management tools. It provides visual and audible warnings to empower users to optimize their insulin therapy. Insulcloud says it promotes the proper use of insulin pens for enhanced safety and control.

The company designed Insulclock CAP to capture critical information, including insulin brand, insulin dose measurement, injection date and time and the temperature of the insulin pen at the time of injection. It also differentiates bolus insulin from priming insulin automatically.

Insulcloud developed its device for patients using disposable pens with type 1 or type 2 diabetes and it works across insulin brands. The company already launched the solution, along with a companion mobile app, in Europe. It said peer-reviewed research revealed a 13.5% improvement in on-time injections and averaged cost saves per patient of nearly $1,000 annually.

The company plans to integrate its offering into existing healthcare apps through an FDA-cleared software development kit. It already began sourcing partners for distribution in the U.S. while considering Boston as the location for its first international office.

“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 minimizing complications and hospitalizations,” said Insulcloud GM Judith Ruiz de Esquide.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Insulcloud