Embecta obtains FDA clearance for disposable insulin patch pump

Embecta (Nasdaq: EMBC), a spinoff from BD Diabetes, has received FDA 510(k) clearance for its new disposable insulin delivery system. Intended for adults with type 1 and type 2 diabetes, this open-loop system features a tubeless design and a 300-unit insulin reservoir. Developed with feedback from type 2 diabetes patients and healthcare providers, it allows for adjustable basal and bolus insulin delivery for up to three days.

The system includes a Bluetooth-enabled controller with a color touchscreen. The clearance follows Insulet's recent FDA approval of its Omnipod 5 for type 2 diabetes. Although Embecta's pump has been approved, there is speculation about a potential sale of the company. Data from ADA 2024 indicates that the 300-unit reservoir is sufficient for 64% of type 2 diabetes patients for 72 hours, compared to 38% for a 200-unit reservoir. The company has not updated its commercial plans post-approval.