FDA Clears Beta Bionics' Mint, Its First Tubeless Insulin Patch Pump

The FDA has cleared Beta Bionics' Mint, the Irvine, California, company's first tubeless insulin patch pump, setting up a US launch in the first quarter of 2027, the company announced on September 14, as reported by MedTech Dive and Healio.

The FDA's 510(k) database lists submission K260001 for the "Mint ACE Pump" from Beta Bionics, received January 2, 2026, and found substantially equivalent on September 11. The device is classified as an alternate controller enabled insulin infusion pump, product code QFG, under regulation 880.5730. On the same day, the agency also cleared K262763, an update to the company's iLet Dosing Decision Software, classified as an interoperable automated glycemic controller.

What the pump is

Mint has a three-day wear time and a 200-unit insulin reservoir, and is built from a mix of disposable and reusable components, MedTech Dive reported. Healio, citing the company's release, said the pump runs for up to three days plus a 12-hour grace period without charging, is controlled from an iOS or Android device, and can be paired with continuous glucose monitors including the Dexcom G7, the Dexcom G7 15-day and Abbott's FreeStyle Libre 3 Plus.

Beta Bionics said Mint is smaller than the patch pump sold by its main competitor, Insulet, according to MedTech Dive. The company's existing product, the iLet Bionic Pancreas, is a tubed pump.

Launch plans and a pending algorithm

Beta Bionics plans a full US launch in the first quarter of 2027, exclusively through the pharmacy channel, and expects to produce at least 1.5 million disposable units in 2027, MedTech Dive reported.

The company has also submitted a new dosing algorithm, 3D Intelligence, to the FDA for 510(k) clearance. It has not been cleared. MedTech Dive reported that it offers three settings: the algorithm currently used on iLet, an updated version drawing on real-world iLet use, and an option that responds more gradually when correcting high glucose. Beta Bionics said the update would provide "a more customizable treatment approach tailored to each user's unique insulin requirements," Healio reported.

"We believe that our next-generation automated insulin delivery platform, consisting of Mint 3D and iLet 3D, will represent a transformational advancement for people living with diabetes, subject to regulatory clearance by the FDA," Sean Saint, Beta Bionics' president and chief executive, said in the release, as quoted by Healio.

Leerink Partners analyst Mike Kratky wrote that the clearance makes Beta Bionics the second company to bring a tubeless patch pump to market, and that the launch is well ahead of the company's earlier expectations, according to MedTech Dive. "[Beta Bionics] having a commercially available patch pump represents a major product enhancement, as this remains a key consideration for patients when deciding between pumps," Kratky wrote.

The company also cut its 2026 revenue forecast by $10 million, to a range of $121 million to $126 million, saying some potential iLet users may wait for Mint, MedTech Dive reported.

The clearance follows an FDA warning letter to Beta Bionics earlier this year. MedTech Dive's archive lists a February 26, 2026 report headlined "FDA warns Beta Bionics on unreported complaints, insulin pump changes." Neither report said whether that letter had been resolved.