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

 
• By Marion Webb

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
• Source: Shutterstock

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...

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Bone Surgery Startup Surgify Medical Raises $7.9m

 
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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

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More from Business

Medtronic Eyes Up to $350M Tariff Hit in FY26, Leans On Cost Controls And Pricing Strategy

 
• By Shubham Singh

Medtronic expects operating profit to grow approximately 7% in fiscal 2026, excluding tariff impacts. If tariffs materialize at the upper end of the projected range, operating profit growth could drop by 2.2 to 3.2 percentage points.

India-UK Free Trade Agreement Sets Stage For Medtech Growth, But Industry Demands Safeguards

 
• By Shubham Singh

Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.

Medtronic To Spin Out Diabetes Unit As New Products Solidify Turn-Around Story

 
• By Shubham Singh

Medtronic’s diabetes spin-out – a process likely to run up to 18 months and involve 20% IPO followed by a split-off for Medtronic shareholders – will allow firm to focus on higher-margin devices.