Insulin delivery technology company Modular Medical has announced the premarket submission of its MODD1 insulin pump to the US Food and Drug Administration (FDA) to obtain 510(k) clearance.
This marks a significant step for the company in launching its next-generation insulin pump, which aims to enhance user-friendliness and affordability in diabetes management.
Modular Medical chairman and chief technology officer Paul DiPerna said: “This is an exciting milestone for the company, as we seek to change the diabetes market. Almost 30 years after the introduction of the first insulin pump, more than three-quarters of those who could benefit from wearing a pump do not wear one.
“It is our belief that our simplified design will encourage many ‘almost-pumpers’ to adopt technology to aid in their diabetes management, without the complexity and expense required by many of the current solutions.”
Designed to be affordable enough for free sampling and trial, MODD1 is simple enough for self-guided user training and use.
Modular Medical CEO Jeb Besser said: “Pump adoption has been impeded by the ‘three-Cs:’ they are too complex, cumbersome and costly. The MODD1 was designed to be simple and affordable with an attractive form factor. We believe our two-part patch pump design, easy-to-learn interface and scalable manufacturing will all contribute to a differentiated and lower-cost marketing approach.
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“While working with the FDA to gain US clearance, our regulatory effort will now turn to preparing applications to obtain the UKCA mark to enable us to market the MODD1 in the United Kingdom. Operationally, we will move our pilot production line to our manufacturing partner to prepare for commercial launch.”
Last year, Modular Medical collaborated with Glooko to integrate the latter’s technology platform into its diabetes care system, enhancing data accessibility for clinicians and patients.