News from the FDA/CDC

FDA approves new tubeless insulin pump


 

The Food and Drug Administration has granted clearance for Roche’s Accu-Chek Solo micropump system, a tubing-free “patch” pump for people with diabetes who use insulin.

A stamp saying "FDA approved." Olivier Le Moal/Getty Images

The product received CE Mark in Europe in 2018 and is now available in 19 markets worldwide. It offers users a choice of bolusing directly from the pump or from a handheld remote-control device. The pump can be detached and reattached without wasting insulin.

The remote-control device also incorporates blood glucose monitoring and bolus advice, although it currently does not integrate with continuous glucose monitoring (CGM) devices.

A Roche spokesperson said in an interview, “For future product generations, we are exploring possibilities to integrate CGM data into the system. Already today, the diabetes manager allows users to manually enter a glucose value that can be used to calculate a bolus. To do so, people with diabetes could use their CGM device of choice in conjunction with the Accu-Chek Solo micropump system.”

Roche will provide an update on next steps for further developments and time lines for launch “in due course,” according to a company statement.

A version of this article appeared on Medscape.com.

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