WILMINGTON, Del.– Amalgam Rx, Inc., the leader in connecting healthcare providers and life sciences companies through a SaaS-enabled digital marketplace and product platform, is announcing it has achieved the Conformité Européenne (CE) Mark for its insulin titration application, iSage Rx™ and its white-labeled variants. The CE Mark demonstrates Amalgam’s commitment to EU standards for quality management, safety, and performance as defined in the Medical Devices Directive 93/42/EEC.
With this CE Mark, iSage Rx’s capacity to support the titration of all basal insulins and enable connectivity to the leading Bluetooth-enabled blood glucose meters from Roche, Lifescan, and Ascensia, is now cleared for the European market. Amalgam’s goal is to simplify the process of insulin dose optimization, including the manner in which people capture and store their blood glucose and insulin dose values. Optimized dosing is critical to insulin’s effectiveness in controlling A1C. Historically, physicians have not had a simple tool to help patients understand and adhere to their prescribed insulin dosing algorithm. As a result, 32% of basal patients are unaware of the need to titrate and 63% are insufficiently titrated.
In early clinical studies, the iSage Rx app has demonstrated the ability to improve patients’ glucose levels by helping them reach the appropriate level of basal insulin. iSage Rx is built on Amalgam’s software as a medical device (SaMD) technology platform, which has been developed in conformity with ISO 13485:2016, SOC 2 Type 2, and the requirements for HIPAA and GDPR.
“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,” said M. Jason Brooke, general counsel and vice president of regulatory and quality of Amalgam Rx.
“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,” said Chris Bergstrom, president of Amalgam Rx.
