The Clearances & Approvals Keep Coming in Diabetes Tech

The last few weeks have been filled with substantial clearances and approvals in the diabetes tech arena.

Embecta kept the space warm by announcing it had won a nod from FDA for its disposable patch pump. The device is indicated for adults who require insulin to manage diabetes, including both type 1 and type 2.

The system also includes a tubeless patch pump design with a 300-unit insulin reservoir that was informed by feedback from people with T2D and their healthcare providers.

“FDA clearance of our disposable insulin delivery system has been a top strategic priority for our team since launching Embecta as an independent company, and achieving this milestone through strong execution exemplifies our commitment to making life better for the growing number of people living with diabetes,” said Dev Kurdikar, CEO. “As we continue to advance toward our vision of a life unlimited by diabetes, our team has focused on developing a patch pump that could address some of the most significant obstacles to adopting pump therapy for people who use insulin daily to manage their diabetes. This platform is also serving as the basis for an automated insulin delivery system in development.”

The company said the system includes a wearable, fully disposable patch pump that provides adjustable basal and bolus insulin for up to three days, depending on the needs of the user. The patch pump features a 300-unit insulin reservoir that accommodates people who have higher daily insulin needs, which is typically true of people with T2D. 

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In a research note, Marie Thibault, an analyst with BTIG, discussed the company's potential launch plans for the device.

“Embecta had previously intended to release the open-loop version via limited launch with one or two sales reps following approval but didn't offer an update on its commercial plans with the release,” Thibault wrote. “Embecta continues to advance its closed-loop version of the pump with an insulin-dosing algorithm and plans to file with FDA in a future submission. We may hear more details at the company's planned investor day in December.”

Embecta’s clearance follows Insulet winning a nod from FDA for the Omnipod 5, an automated insulin delivery system. Insulet’s clearance was almost lockstep with FDA giving the OK to Dexcom’s Stelo, an over-the-counter continuous glucose monitor system.