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

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

SEPTEMBER 25, 2024 BHH Members Initiatives

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

February 18, 2025 BHH Members Initiatives
FisioReact raises €1M to continue transforming at-home physiotherapy in Spain
The company will use the investment to accelerate its growth across Spain and enhance the patient experience by integrating in-person and online care.
Read more
February 17, 2025 BHH Members Initiatives
INVOX Medical strengthens its leadership in AI adoption for medical documentation
INVOX Medical is advancing its 2025 roadmap with the launch of new solutions to cover all scenarios where healthcare professionals need to document information.
Read more
February 17, 2025 BHH Members Initiatives
How Open Medical has transformed trauma management across an entire region
Discover the Case Study of Open Medical and How they've transformed trauma management across an entire region.
Read more
February 14, 2025 BHH Members Initiatives
Viduet Health achieves highest score for heart failure care in European Union tender TIQUE-PCP
Viduet Health has achieved this highest score for heart failure care in European Union tender TIQUE-PCP, with Hospital de Sant Pau Barcelona patients included early this year.
Read more
February 13, 2025 BHH Members Initiatives
Wearables and AI to improve patient health
Wearables, combined with artificial intelligence, are revolutionizing healthcare. Their integration marks a significant step toward accessible, preventive care focused on improving overall health and well-being.
Read more
February 12, 2025 BHH Members Initiatives
Babel joins forces with SocialDiabetes and Listen.Doctor in a new strategic alliance
This alliance aim to deploy Artificial Intelligence–based models in the healthcare and insurance sectors in Spain, Portugal, Chile, Costa Rica, Colombia, and the United States.
Read more
February 11, 2025 BHH Members Initiatives
Between Technology stands out in 2024 with a 10% sales growth and surpasses 1,000 employees
The technology company increases inclusion in the ICT sector, with women making up 28% of its workforce—exceeding the national and European average.
Read more
February 11, 2025 BHH Members Initiatives
How should health data be defined and used across Europe?
A public consultation is now open to define how health data should be described, made discoverable, accessed and used across all of Europe. 
Read more
February 11, 2025 BHH Members Initiatives
i4KIDS-EUROPE publishes report "Challenges and Opportunities for Effective Paediatric Innovation in Europe"
The report, published by the i4KIDS-EUROPE consortium, examines the state of pediatric innovation and includes recommendations to boost the pediatric and maternal health innovation sector in Europe.
Read more
February 04, 2025 BHH Members Initiatives
Don't miss Kunsen's report on "New Frontiers in Oncological Patient Care"
The report underscores their importance in enabling society to manage resources more efficiently and make them accessible to a broader population.
Read more