Modular Medical (NASDAQ: MODD) has announced that the Institutional Review Board (IRB) has granted approval to conduct an in-house study of its next-generation Pivot insulin delivery system using insulin on people with diabetes.
According to Modular, the study will simulate real-world conditions by delivering insulin to adult participants to gather critical data on device function and usability and obtain user feedback.
In a statement, Jeb Besser, CEO of Modular, commented, “This IRB approval marks another important milestone in advancing our tubeless insulin pump technology toward market readiness. We now have approval to gather real-world data delivering insulin to adult test subjects in a controlled environment, as we await FDA feedback on our recent Pivot 510k submission. Once FDA clearance is achieved, we believe our Pivot pump will be well positioned to achieve rapid adoption in the growing wearable diabetes technology sector.”
The company notes that the Pivot insulin delivery system is not currently FDA-cleared for sale.
