Update – 9/17/2019 – At the EASD Conference in Barcelona, DreaMed announced that its DreaMed Advisor Pro software has gained expanded FDA approval and EU approval for use with blood glucose monitors. This is in addition to previous approval for the software to be utilized with insulin pumps and continuous glucose monitors.
By Craig Idlebrook/GluCraig
The FDA has approved new artificial-intelligence-based software that will help healthcare professionals make insulin dosing recommendations for people with type 1 diabetes.
On June 18, 2018, Israel-based DreaMed announced that its DreaMed Advisor Pro software has received FDA marketing clearance. The Advisor Pro utilizes data from insulin pumps and continuous glucose monitors (CGMs) to provide healthcare providers with recommendations for suggested changes in insulin pump basal rates, carb ratio, and correction factor. In 2016, DreaMed had entered into an agreement to integrate the Advisor Pro into the Glooko diabetes data management platform.
The FDA clearance marks the first yield from a series of investments into DreaMed AI algorithms for diabetes care. In 2016, the Helmsley Charitable Trust invested $3.4 million in DreaMed to help it develop the software; this led to the partnership with Glooko. A year earlier, Medtronic invested $2 million in DreaMed for the right to license the company’s GlucoSitter technology for integration into future insulin pumps.
Earlier, DreaMed earned the European Union’s CE mark for the Advisor Pro.
The FDA granted the Advisor Pro de novo clearance. This means that FDA regulators found no real equivalent to the software on the market. Such a designation can slow down the clearance process, as the FDA could classify the device or software as a Class III device, the kind that pose the highest risk to safety; it is then up to the company to prove it should be classified as Class II or Class I (less risky). Under recently streamlined rules, however, a company can apply for de novo status while simultaneously asking regulators to skip this step and classify the device or software in the lowest risk category possible.
A press release by DreaMed did not give a timeline for integrating the Advisor Pro software into Glooko software. We will keep you posted when we learn more about a timeline for the Advisor Pro software being available on the open market.