Amalgam has obtained CE mark to market its insulin titration application, iSage Rx, and its white-labelled variants in the European region.
iSage Rx is designed to aid in the titration of all basal insulins. It can be connected to the Bluetooth-enabled blood glucose metres of Roche, Lifescan and Ascensia.
Amalgam aims to streamline the process of insulin dose optimisation, including how individuals collect and store their blood glucose and insulin dose values.
The company noted that optimised dosing is vital to the effectiveness of insulin in regulating glycated haemoglobin (A1C).
So far, no simple tool was available to aid patients in understanding and sticking to the insulin dosing algorithm prescribed by the physician.
Consequently, 32% of basal patients are not aware of the titration requirements and 63% are inadequately titrated.
Amalgam Rx regulatory and quality general counsel and vice-president M Jason Brooke said: “With the issuance of this CE mark certificate, Amalgam continues to demonstrate that our global regulatory capabilities support the scale necessary to help millions of people achieve healthier lives.
“Expanding into new geographies requires a detailed understanding of the local legal and regulatory framework, as well as the quality infrastructure to import digital health solutions in a compliant manner.”
In previous clinical studies, the iSage Rx app was able to enhance the glucose levels of patients by facilitating the correct basal insulin level.
The app is built on the company’s software as a medical device (SaMD) technology platform.
Amalgam also announced a worldwide expansion of its insulin titration solution in partnership with Novo Nordisk.
In the initial stage, the companies marketed a white-labelled version of iSage Rx, named Dose Check, in some South American countries.
With iSage Rx and Dose Check obtaining CE mark, Novo Nordisk intends to market the app globally.
Dose Check will be introduced in various countries in Europe and Asia this year, the company noted.