Novo Nordisk extends the Amalgam Rx collaboration to introduce a new CE-marked insulin administration app in Europe

Do I need to know how much insulin I administer throughout the day and stick to doses that fluctuate over time? There is an app for that.

Its insulin titration app, Amalgam Rx’s iSage Rx, has obtained the CE mark for all rebranded versions of the original software and app and will soon be available in Europe.

This marks the third global clearance of iSage Rx. The app was launched in the United States in 2017, received 510 (k) approval from the FDA, and was later approved by the Brazilian regulator ANVISA.

The amalgam prescription-only app allows you to choose from several clinically validated insulin dosing algorithms and tailor them to the individual needs of people with type 2 diabetes.

Relation: Digital Health Player Amalgam Rx Released in Type 2 Diabetes App

Patients who do not use insulin pumps or dietary insulin should self-administer different levels of insulin throughout the day based on changes in blood glucose levels due to physical activity and food intake. This is a process called insulin titration.

According to amalgam, more than 60% of basal insulin users are under-titrated without simple, easy-to-use tools and apps that help patients understand and comply with changes in insulin doses, and this patient group. About one-third of them are completely unaware of the need to titrate insulin.

ISage Rx aims to solve these problems by connecting to a Bluetooth-equipped glucose meter such as Roche, Lifescan, Ascensia, etc. and collecting blood glucose and insulin measurements in one place. ..

The app also provides patients with behavioral support and educational information about titrations, helping them better understand the process and its potential impacts, as well as increasing the likelihood that patients will adhere to their personalized medication plans. I will.

“Scaling prescription digital solutions remains one of the last frontiers in digital health.” Said Chris Bergstrom, president of Amalgam. “We also need the ability of amalgam to sell these products and integrate them into the workflow of providers and the daily lives of patients. This end-to-end expertise has attracted many of the world’s largest healthcare companies to our platform. The platform currently supports millions of patients and thousands of providers worldwide. ”

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Amalgam Rx has obtained the CE mark and expanded its partnership with Novo Nordisk to provide a rebranded version of iSage Rx to European diabetics who use Novo’s range of insulin.

Their collaboration began in 2019 with the release of a Novo-specific app called DoseCheck in Brazil. Currently, throughout 2021, amalgam and Novo will bring dose checks to several European countries. iSage Rx technology has not yet been approved by regulators on the continent, but the two companies plan to launch DoseCheck in Asia this year.

“The dose check program is evidence of Amalgam’s unique capabilities that support life sciences companies from R & D to commercialization. Amalgam now has software as a clear medical device solution on three continents. Ryan Cisco, Founder and Chief Executive Officer, said: statement.. Novo Nordisk extends the Amalgam Rx collaboration to introduce a new CE-marked insulin administration app in Europe

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