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AmalgamRx secures CE Mark for its insulin titration algorithm

Digital therapeutics company AmalgamRx recently announced that it has received EU CE Mark approval for its insulin titration algorithm, called iSage Rx, and its white-label variants, and concluded a commercialisation agreement with Novo Nordisk.

The green light for operation in the EU market comes more than four years after FDA approval in the U.S. for the prescription technology.

In collaboration with device manufacturers including Roche, Lifescan and Ascensia, iSageRx allows people living with diabetes to use the app for basal insulin titration. The tool was developed to help users simplify their insulin dosing process and manage their A1C levels by capturing and storing blood glucose data. 

The introduction of the solution in Europe will be further accelerated by a commercialisation agreement with Novo Nordisk, a diabetes startup, to expand the white-label version of AmalgamRx’s iSage Rx app, called Dose Check, in both Europe and Asia.

And while Novo Nordisk has its own connected insulin pen, it remains to be seen whether the partners will introduce any integration between Dose Check and the smart pen.

Diabetes is a common disease worldwide. According to the World Health Organisation, in 2014, 422 million people were living with the disease worldwide. The condition can be successfully managed through diet, physical activity and medication.

In Europe, where iSage is now approved for commercial release, approximately 60 million people are living with diabetes, or approximately 10.3 percent of men and 9.6 percent of women over the age of 24, according to WHO data.

Chris Bergstrom, president of AmalgamRx, explained in a statement how scaling digital prescription solutions is crucial to the evolution of digital health. With the company having received regulatory approvals on three continents, it’s safe to say that AmalgamRx is well poised to deliver on its solution by bringing its products to market and integrating them seamlessly into providers’ workflows and patients’ daily lives. 

Speaking about the company’s recent expansion in the market, Bergstrom was quick to point out that in addition to clearance, it is this end-to-end expertise that has attracted many of the world’s largest healthcare companies to its platform, which now supports millions of patients and thousands of providers around the world.

Established by WellDoc founders Ryan Sysko and Dr. Suzanne Clough in 2017, AmalgamRx has recently moved in a series of acquisitions, the most notable being the acquisition of clinical decision support company Avhana Health for an undisclosed sum just this past January. That was shortly followed by the acquisition of conversational AI tool Geetha, which has developed AI models capable of learning the behavior of patients and healthcare stakeholders and in turn providing content designed to change behavior.

While AmalgamRx is expanding rapidly, it is not the only player in the space, with Glooko, a competing insulin titration tool developer, also being awarded FDA clearance in 2018.

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