Analyst Expects Roche’s Newly FDA-Cleared Insulin Patch Pump Will Have ‘Limited Impact’

Roche received FDA clearance for its Solo insulin patch pump, but is expected to face significant barriers to entry in the highly competitive US insulin pump market.

Roche
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Roche recently received 510(k) clearance from the US Food and Drug Administration for its Accu-Chek Solo insulin patch pump, which looks similar to Insulet Corporation’s Omnipod patch pump.

The device has been available in Europe since 2018. But Wells Fargo analyst Larry Biegelsen wrote in his 21 August note that interviews with diabetes key opinion leaders suggest that adoption of the device “seems to be limited” in Europe. He cited manufacturing issues, availability in only select countries, as well as lack of continuous glucose monitoring (CGM) compatibility

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