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FDA Clears Beta Bionics' Mint Reusable Insulin Patch Pump
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Fusion42 · 16 September 2026 · Fusion42 review
The US FDA has cleared Beta Bionics' Mint, a reusable insulin patch pump that integrates continuous glucose monitoring and smartphone control, with commercial launch expected in early 2027. The company also submitted a next-generation automated insulin dosing algorithm, 3D Intelligence, pending FDA clearance.
This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 14 Sep 2026 and 15 Sep 2026.
◆ ◆ The Wire takeaway
Diabetes device founders face new market entry as FDA approval opens US sales of reusable insulin patch pumps controlled by smartphones. Beta Bionics' pending algorithm clearance signals a move to more personalised automated insulin delivery that you can prepare to support or compete against soon.
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2 sources · first reported 14 Sep 2026 · latest 15 Sep 2026
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