Insulcloud Gains FDA Clearance to Expand Insulclock CAP in the US

Insulcloud announced its strategic expansion into the U.S. market following the FDA’s clearance of its Insulclock CAP smart device. This commercialization milestone underscores the safety, efficacy, and quality of the Insulclock CAP, and helps clear the way for millions of Americans living with diabetes to take control of their insulin therapy with unprecedented precision and confidence.  

It is designed to monitor patient use of disposable insulin pens and increase adherence to prescribed therapy. The Bluetooth-enabled device provides visual and audible warnings to optimize insulin therapy and promote the proper use of insulin pens for enhanced safety and control. 

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

The Insulclock CAP is designed for patients using disposable insulin pens who have been diagnosed with type I or type II diabetes mellitus, and it works across insulin brands. The diabetes care solution and the app are already in use across Europe. 

“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 General Manager Judith Ruiz de Esquide. “At Insulcloud, we believe that everyone deserves access to life-changing technology. Together, we can transform diabetes care for the better, paving the way for a healthier future.” 

The technology is validated* in peer-reviewed research to improve on-time injections by 13.5%. Adopting the Insulcloud Insulclock CAP solution has shown an average cost savings per patient of nearly $1,000 annually.

Insulclock is designed to be integrated into existing healthcare apps through an Insulclock FDA-cleared software development kit (SDK). 

Insulcloud is now in the process of sourcing partners for distribution into the U.S. market and is considering locating its first international office in Boston.