Clearance Covers Software Enhancements for Greater Patient Flexibility and Pivot Customization
SAN DIEGO, CA / ACCESS Newswire / September 3, 2026 / Modular Medical, Inc. ("Modular Medical" or "the Company") (NASDAQ:MODD), a commercial-stage medical device company preparing for the full commercial launch of its next-generation Pivot tubeless patch pump, today announced that the U.S. Food & Drug Administration (FDA) has cleared a set of software enhancements to its Pivot insulin delivery system, further expanding the system's functionality and providing users with greater flexibility and customization options in bolus dosing, an enhanced user-interface (UI), and other software upgrades.
"We are pleased that this clearance was received in advance of our planned fourth quarter launch. The cleared improvements represent the first in a series of enhancements and upgrades to the Pivot platform and were designed to expand the functionality and flexibility of Pivot for users, including the ability to customize the amount of insulin delivered with each button push. We are proud of the team's performance in obtaining this clearance and look forward to bringing these enhanced capabilities to customers," said Jeb Besser, Chief Executive Officer of Modular Medical.
For more information on the Pivot system, visit the dedicated site: PivotPump.com and the YouTube Pivot Insulin Delivery System channel searchable @ModularMedical.
About the Pivot Tubeless Patch Pump
The Pivot tubeless patch pump is a simple, wearable insulin delivery platform designed to provide continuous subcutaneous insulin infusion with both basal and bolus insulin delivery over a three-day wear period. The system is intended to offer a practical and accessible pathway from multiple daily injections to insulin pump therapy for a broader population of people living with diabetes. For more information, visit www.pivotpump.com.
About Modular Medical
Modular Medical, Inc. (NASDAQ:MODD) is a commercial-stage medical device company that is commercializing the next generation of insulin delivery technology. Using its patented technologies, the Company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn. Its mission is to improve access to the highest standard of glycemic control for people with diabetes taking it beyond "superusers" and providing "diabetes care for the rest of us."
Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding Modular Medical, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump. More information is available at https://www.modularmedical.com.
Pivot is a trademark of Modular Medical in the United States. All other trademarks mentioned herein are the property of their respective owners.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statements contained in this press release, including but not limited to, the planned full commercial launch of the Pivot platform in the fourth quarter of 2026, the Company's plans to make further improvements and upgrades to the Pivot platform and whether such improvements and upgrades to the Pivot platform will be approved by the FDA, the Company's ability to convert patients to use its Pivot pump product, successful development of Modular Medical's proprietary technologies, whether the market will accept Modular Medical's products and services, anticipated consumer demand for the Company's products, whether Modular Medical can successfully manufacture its products at high volumes, general economic, and industry or political conditions in the United States or internationally, as well as other risk factors and business considerations described in Modular Medical's SEC filings, including its annual report on Form 10-K. Any forward-looking statements in this press release should be evaluated in light of these important risk factors. In addition, any forward-looking statements included in this press release represent Modular Medical's views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. Modular Medical assumes no obligation to update these forward-looking statements, except as required by law.
Company Contact:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
IR@modular-medical.com
Investor Contact:
Valter Pinto
Managing Director
KCSA Strategic Communications
ModularMedical@KCSA.com
SOURCE: Modular Medical, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/modular-medical-announces-fda-clearance-of-pivot-tubeless-insulin-pat-1216140
