Beta Bionics announced on 14 September that the US Food and Drug Administration has cleared Mint, its tubeless insulin patch pump. MedTech Dive reports that the clearance makes Beta Bionics the second company to bring a tubeless patch pump to market, after Insulet. Full US commercialisation is planned for the first quarter of 2027.

A two-piece patch

Mint has a two-piece architecture, with one reusable part and one disposable part. According to the company, each disposable is worn for three days plus a 12-hour grace period and holds 200 units of insulin. The pump never needs recharging and is rated IPX8 for water resistance to 5 feet for 60 minutes. Beta Bionics describes Mint as smaller than industry-leading patch pumps, and MedTech Dive reports that it is smaller than Insulet’s. It is controlled from a smartphone and can receive firmware updates over the air.

Splitting the device matters for the economics of wearable electronics. A fully disposable patch pump discards its electronics every few days, while a reusable part changes both the cost per wear and the environmental case. The announcement does not say which components sit in which part.

Sensors and software

Mint works with the Dexcom G7, Dexcom G7 15 Day and Abbott FreeStyle Libre 3 Plus continuous glucose monitors. Beta Bionics has also submitted a 510(k) application for 3D Intelligence, a new dosing algorithm with Original, Optimized and Conservative settings. Subject to clearance, it expects to launch iLet 3D by the end of 2026 and Mint 3D in the first quarter of 2027.

Patch pumps are a demanding category for wearable electronics. The device carries an insulin reservoir, a pumping mechanism, a power source, a radio and control electronics on the skin for days at a time. It has to tolerate water and keep a reliable link with both a phone and a glucose sensor. Beta Bionics’ claims that Mint never needs recharging and is rated IPX8 speak to the power and sealing sides of that problem. The announcement we read gives no size or weight figures.

Scale and guidance

The company plans to manufacture at least 1.5 million Mint disposable units in 2027. MedTech Dive reports that it will distribute exclusively through the pharmacy channel. Beta Bionics also cut its full-year 2026 revenue guidance to $121–126 million from $131–136 million. MedTech Dive reports the company expects some potential users of its tubed iLet pump to wait for Mint.

Mint joins a busy month for skin-worn drug and monitoring devices, including the FDA’s breakthrough designation for Nutromics’ vancomycin monitoring patch.

What we’re watching

  • Whether the first-quarter 2027 launch holds, and early data on wear comfort.
  • The FDA’s decision on the 3D Intelligence algorithm.
  • Pharmacy pricing for the reusable and disposable parts.