Modular Medical Announces FDA Clearance of Pivot Tubeless Insulin Patch Pump Enhancements

FDA clearance of Pivot software upgrades supports Modular Medical’s planned Q4 2026 launch and adds customization and usability features for insulin dosing.

Rhea-AI Summary

Modular Medical (MODD) received FDA clearance for software enhancements to its Pivot tubeless insulin patch pump system, expanding functionality ahead of its planned fourth quarter 2026 commercial launch.

The clearance covers upgrades that provide greater flexibility and customization in bolus dosing, an enhanced user interface, and other software improvements. The company said these are the first in a series of planned enhancements to the Pivot platform, including the ability to customize the amount of insulin delivered with each button press. Pivot is designed as a simple, wearable insulin delivery system providing continuous basal and bolus insulin over a three-day wear period, with the aim of offering an accessible alternative to multiple daily injections for a broader diabetes population.

Positive

• FDA clearance obtained for software enhancements to the Pivot insulin delivery system, expanding functionality and usability.
• Clearance timing comes ahead of the planned fourth quarter 2026 commercial launch of the Pivot tubeless patch pump.
• Bolus dosing customization now includes the ability to adjust insulin delivered with each button push.
• Enhanced user interface and other software upgrades aim to make Pivot more accessible for a broader diabetes population.

Negative

• None.

Market Reaction – MODD

+0.58% $3.48 11.3x vol

15m delay

+0.58% Vs previous close

-3.6% Trough in 5 min

$3.48 Last Price

$3.14 $4.14 Day Range

$28.36M Market Cap

11.3x Rel. Volume

Following this news, MODD has gained 0.58%, reflecting a mild positive market reaction. Argus tracked a trough of -3.6% from its starting point during tracking. Our momentum scanner has triggered 12 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $3.48. Trading volume is exceptionally heavy at 11.3x the average, suggesting very strong buying interest.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Market Context

On 2026-09-02, MODD recorded a -2.67% pre-publication daily move. That baseline frames the clearance...

Analysis

On 2026-09-02, MODD recorded a -2.67% pre-publication daily move. That baseline frames the clearance as new information against existing weakness; the active S-3 resale registration and planned launch remain factors to monitor.

Key Figures

Launch timing: fourth quarter Wear period: 3 days

2 metrics

Launch timing fourth quarter Planned Pivot commercial launch

Wear period 3 days Pivot tubeless patch pump

Previous Fda approval Reports

1 past event · Latest: Sep 04 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	24h Move	Catalyst
Sep 04	FDA clearance	Positive	+12.9%	FDA clearance of MODD1 insulin pump preceded a 12.93% 24-hour gain.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

The tag-matched FDA-clearance event aligned with a positive 12.93% 24-hour reaction.

Key Terms

fda, bolus dosing, continuous subcutaneous insulin infusion, basal insulin

4 terms

fda regulatory

"the U.S. Food & Drug Administration (FDA) has cleared"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

bolus dosing medical

"greater flexibility and customization options in bolus dosing"

Bolus dosing is giving a drug or biologic as a single, relatively large dose delivered quickly—often by injection—to raise blood levels rapidly, rather than slowly over time. Investors care because bolus administration affects how a therapy works, its safety profile, trial design, and dosing convenience; think of it like turning a faucet on full to reach a target level instantly versus dripping steadily to maintain it.

continuous subcutaneous insulin infusion medical

"continuous subcutaneous insulin infusion with both basal and bolus insulin delivery"

A therapy that uses a small wearable pump to deliver insulin under the skin through a thin tube, providing a steady baseline dose plus extra doses around meals to control blood sugar. Think of it like an automated drip and on-demand button combined, replacing multiple daily injections. It matters to investors because pump sales, consumable supplies, software updates, regulatory approvals and reimbursement policies drive revenue, adoption rates and competitive dynamics in the diabetes care market.

basal insulin medical

"with both basal and bolus insulin delivery over a three-day wear period"

A long-acting form of insulin that people with diabetes use to keep blood sugar steady throughout the day and night, acting like a slow-release background dose rather than a quick corrective shot after meals. Investors care because basal insulin represents a large, recurring-market product category with predictable demand, pricing and patent competition; changes in treatment guidelines, new delivery methods or patent expiries can materially affect a company’s sales and future growth.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

FAQ

What FDA clearance did Modular Medical (MODD) receive for the Pivot insulin pump?

Modular Medical received FDA clearance for a set of software enhancements to its Pivot tubeless insulin patch pump system, including expanded bolus dosing flexibility, an enhanced user interface, and other software upgrades that increase functionality for users.

How do the new Pivot software enhancements benefit users of MODD’s insulin patch pump?

The cleared enhancements provide greater flexibility and customization in bolus dosing, including the ability to customize insulin delivered with each button press, plus an enhanced user interface and other software upgrades designed to improve overall usability of the Pivot system.

How does the FDA clearance affect the planned launch of the Pivot system by Modular Medical (MODD)?

The company said the clearance was received before its planned fourth quarter 2026 launch of the Pivot tubeless patch pump, supporting the introduction of the system with the newly approved software features already incorporated.

What is the Pivot tubeless patch pump described by Modular Medical (MODD)?

Pivot is a wearable tubeless insulin patch pump designed to provide continuous subcutaneous insulin infusion with both basal and bolus delivery over a three-day wear period, aiming to offer a practical pathway from multiple daily injections to pump therapy for a broader diabetes population.

Where can patients and investors find more information about the Pivot insulin delivery system from MODD?

More information on Pivot is available at PivotPump.com and on the YouTube Pivot Insulin Delivery System channel searchable as @ModularMedical, with additional company details at the Modular Medical corporate website.