Digital health company Amalgam Rx has achieved the CE Mark for its insulin titration application, dubbed iSage Rx, and its white-labelled variants.

iSage Rx supports the titration of all basal insulins and connects to the Bluetooth-enabled blood glucose meters from Roche, Lifescan, and Ascensia.

The regulatory approval confirms that the company’s insulin titration application is in line with EU standards for quality management, safety, and performance, and allows its use in the EU.

Amalgam said that it aims to simplify the process of insulin dose optimisation, including the way people capture and store their blood glucose and insulin dose values.

Amalgam Rx general counsel and regulatory and quality 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.”

According to the company, physicians are historically lacking a simple tool to help patients understand and adhere to their prescribed insulin dosing algorithm.

While optimised dosing is critical to insulin’s effect in controlling A1C, 32% of basal patients are unaware of the need to titrate and 63% are insufficiently titrated.

Amalgam has developed the iSage Rx was based on its software as a medical device (SaMD) technology platform, which conforms with ISO, SOC 2 Type 2, along with HIPAA and GDPR requirements.

In early clinical studies, iSage Rx app has improved patients’ glucose levels by helping them reach the appropriate level of basal insulin, said the company.

Amalgam Rx president Chris Bergstrom said: “Scaling prescription digital solutions remains one of the final frontiers of digital health. Having achieved regulatory clearance across three continents is a critical Amalgam milestone.

“Amalgam’s capabilities to market those products and integrate them into the provider workflow and patient’s daily lives are also necessary.

“It’s this end-to-end expertise that has attracted many of the world’s largest healthcare companies to our platform, which now supports millions of patients and thousands of providers across the globe.”