Modular Medical wins FDA clearance for Pivot tubeless insulin patch pump

Modular Medical (Nasdaq:MODD) announced today that it received FDA 510(k) clearance for its next-generation insulin patch pump.

Pivot, a tubeless patch pump, consists of two parts, with a 3 mL reservoir and a disposable battery. It features smartphone connectivity for bolus and monitoring, plus electronic accuracy without tubes or constant wear.

The pump requires no battery recharging and has removability for showering, sports or discretion. Its quick bolus button enables insulin delivery without a separate controller.

San Diego-based Modular Medical targets “almost-pumpers” on multiple daily injections (MDI) with its insulin pump. It hopes to deliver an option for adults with type 1 or type 2 diabetes with hesitancy toward traditional pumps. The company believes Pivot offers simplicity, affordability and flexibility. It hopes to improve adoption and long-term outcomes while reducing costs.

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