After our recent updates on clinical trials and overall company progress, this month we wanted to provide an update on our progress with the Aktiia product.
The path to market for a medical device like ours takes time and significant validation. We’ve had our full stack hardware and software solution built and functional for over a year now. Last year, we started out our validation with internal testing, and then expanded to external usability testing and clinical trials. Now that our clinical trials have been completed, we are awaiting FDA clearance and CE mark before we can go to market.
In the meantime, we have been continuing to improve our supply chain and rigorously test our product further. We have just completed another build of new devices at our manufacturer, who is ready to scale up for production after clearance. Until then, we are using this batch of devices for further in-depth beta testing in Switzerland with new users.
We’re excited to bring to market a product that has been thoroughly tested not just for the accuracy of its algorithms, but also for a well-rounded user experience. Our goal is to help our users measure and manage their blood pressure with a product experience that seamlessly blends into their daily lives, across both the bracelet and the mobile app. It is this focus on both accuracy and user experience that earned us a favorable write-up in Medscape’s recent analysis of the future of cuffless blood pressure monitors. Medscape is one of the most trusted online resources for doctors, and we are proud to be able to stand up to their scrutiny.
As we move full steam ahead toward product launch, we’re looking forward to keeping you informed on our progress. We’d heard from some subscribers that they wanted another update on the product, which lead to this email. So we’d like to hear more from you – what topics would you like to read more about in our future updates?