Beta Bionics insulin patch pump scores FDA clearance

Beta Bionics (NASDAQ: BBNX) has claimed an FDA clearance for its first patch pump insulin delivery system, amid plans to roll out an updated diabetes dosing algorithm and the launch of a new CGM partnership with Senseonics.

The three-day, wearable Mint carries a 200-unit insulin reservoir as well as a combination of reusable and disposable hardware, and is designed to never need recharging. Beta Bionics also bills it as smaller than the leading patch pump, rival Insulet’s Omnipod 5.

The company said it plans to produce at least 1.5 million disposable units during the next calendar year, following an earlier-than-expected U.S. commercial launch in the first quarter of 2027 aimed exclusively at pharmacy shelves. Beta Bionics had previously pegged Q2  for Mint’s launch.

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