Tandem Diabetes Care (NSDQ:TNDM) said today that it won 510(k) clearance from the FDA for a wireless updater for its insulin pumps.
San Diego-based Tandem, which makes the t:slim, t:slim G4 and t:flex pumps, said it plans to roll out the device updater in a series of test groups this summer before an expanded launch later in the year.
“This clearance, combined with the flexibility provided by our pumps’ touchscreen interfaces, uniquely positions Tandem as the only insulin pump company with the ability to provide its customers access to new and enhanced features, separate from the typical multi-year warranty hardware replacement cycle,” president & CEO Kim Blickenstaff said in prepared remarks. “It’s a way to deliver ongoing innovation to our customers faster than the industry has been able to in the past, which is of particular significance as our artificial pancreas efforts accelerate.”
Last September the FDA approved a version of the t:slim pump with an integrated G4 Platinum continuous glucose monitor made by Dexcom (NSDQ:DXCM).
Tandem had announced the deal with DexCom back in July 2015, when it also beat expectations with its 2nd-quarter results. In August of that year, DexCom won FDA pre-market approval for its G5 mobile CGM, the 1st approved monitor to send data directly to smartphones without a separate receiver.