Modular Medical announced an update on the development of its initial insulin pump product. The Company has continued to make progress on the testing required for its 510(k) submission to the U.S. Food and Drug Administration of its MODD1 insulin pump product. The Company has identified certain material in the pump device that was incompatible with the sterilization process utilized. As previously announced, this compatibility issue has delayed the Company’s 510(k) submission timeline. The Company has identified replacement materials, which are being qualified for use in the product. Given the expected resolution of the compatibility issue, the Company now expects to make its submission to the FDA during the quarter ended June 30, 2023.
Published first on TheFly
