FDA Clears Software Enhancements to Modular Medical's Pivot Tubeless Insulin Pump

The US Food and Drug Administration has cleared a set of software enhancements to Modular Medical's Pivot tubeless insulin patch pump, including more flexible bolus dosing and an updated user interface, the San Diego company announced on September 3.

The FDA's 510(k) database lists submission K262153 for the Pivot Insulin Delivery System from Modular Medical, Inc. The agency received the traditional 510(k) on June 26, 2026, and issued a decision of substantially equivalent on September 2. The device is classified under regulation 880.5725 with product code LZG.

The company said the cleared changes give users more customization options for bolus doses, including the ability to set how much insulin is delivered with each button push. It also cited an enhanced user interface and other software upgrades, without listing them in detail.

Second clearance this year

The base Pivot pump was cleared in April. In its April 9 release, Modular Medical described Pivot as a two-part tubeless patch pump with a removable 3 mL reservoir, a disposable battery, smartphone connectivity for bolus and monitoring, and a bolus button on the pump so a separate controller is not needed. The company said it is designed for adults with type 1 or type 2 diabetes who are hesitant to move from multiple daily injections to a traditional pump, a group it calls "almost-pumpers."

At that time, Modular Medical said software enhancements including variable bolus, improved alarms and compatibility with automated insulin delivery were in development. It submitted the first set of enhancements to the FDA on July 1. The September clearance does not cover automated insulin delivery; the company has not said when it expects to file for that capability.

According to the company, Pivot delivers both basal and bolus insulin under the skin over a three-day wear period.

Launch timing

"We are pleased that this clearance was received in advance of our planned fourth quarter launch," said Jeb Besser, Modular Medical's chief executive. He said the cleared improvements are "the first in a series of enhancements and upgrades to the Pivot platform."

Modular Medical, which trades on Nasdaq under the ticker MODD, is preparing for the full commercial launch of Pivot in the fourth quarter of 2026, according to the release. The company was founded by Paul DiPerna, who earlier founded Tandem Diabetes and designed its t:slim insulin pump. In April, the company said it was targeting a European CE mark in the fourth quarter of 2026 or the first quarter of 2027. It did not disclose pricing for Pivot in the September announcement.