Beta Bionics has received FDA approval for its innovative Mint patch pump, promising a new tailored approach to insulin delivery, alongside the launch of its advanced 3D Intelligence algorithm aimed at enhancing diabetes management in the US market by 2027.
Beta Bionics said the US Food and Drug Administration has cleared Mint, its new patch pump, as the company looks to widen its offer for people using automated insulin delivery systems. The device uses a two-piece design with reusable and disposable elements, can be controlled by smartphone and is built to work with leading continuous glucose monitors, according to the company. The clearance marks a further step in Beta Bionics’ push beyond its current iLet system.
The company also unveiled 3D Intelligence, a next-generation insulin dosing algorithm that has been submitted to the FDA under the 510(k) route, which is commonly used for medical devices that seek clearance by showing they are substantially equivalent to existing products. Beta Bionics said the software is designed to give clinicians three selectable algorithm settings, allowing treatment to be tailored more closely to a patient’s needs.
Mint is expected to reach the US market in the first quarter of 2027, earlier than an earlier target cited by MedTech Dive, which reported the company had previously aimed for the end of the second quarter of that year. Beta Bionics said it expects to be able to produce at least 1.5 million disposable Mint units in 2027 and plans to sell the pump through the pharmacy channel, where it said coverage could eventually extend to at least half of insured US lives.
The company also trimmed its 2026 revenue outlook, saying some prospective iLet users could delay purchases while waiting for Mint. That comes after the FDA cleared Beta Bionics’ iLet ACE Pump and iLet Dosing Decision Software in 2023 for people aged six and older with type 1 diabetes, underscoring how quickly the company is trying to build a broader product line around its dosing algorithm.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
