FDA grants clearance of Insulcloud's Insulclock® pro injection data capture

BHH member Insulcloud is pleased to announce that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Insulclock® pro device within the United States. This clearance is a testament to Insulcloud's commitment to quality and innovation in the healthcare industry.

Insulclock® pro is a reusable medical device with Software Development Kit (SDK) that detects and stores insulin dose-related data when attached to a disposable insulin pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology which can display the brand of insulin, dose amount, injection date, injection time, and ambient temperature. Insulclock® pro is indicated for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus.

With this significant milestone, Insulcloud is now authorized to enter the U.S. market, providing healthcare professionals and patients with access to their state-of-the-art medical device. The FDA's clearance underscores the safety, efficacy, and quality of Insulclock® pro, and represents a key step in Insulcloud’s global expansion strategy.

This development will enable Insulcloud to strengthen their relationships with current and future partners, ensuring that their products reach those who need them most.

Discover more about Insulclock® at their website HERE.