DXCM faces an FDA warning over manufacturing issues, but operations remain unaffected. However, supply-chain risks and rising ...

but Stelo is Dexcom's first product that does not require a prescription. While most Type 1 patients can already get insurance coverage for the sensors, Stelo is now accessible to millions of Type ...

So, she was very frustrated at that appointment, which… it’s things like that that make me understand this is not a game,” said Raheem Seriki, a Type One diabetes patient. For thousands of people ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Adults in the US who want to measure their blood glucose levels using a wearable sensor will soon be able to buy one over-the-counter (OTC) for the first time. The FDA has cleared Dexcom’s Stelo ...

Management does not expect the FDA’s review of Dexcom’s 15-day sensor to be affected, the analysts added. Dexcom received FDA observations “related to process improvement and documentation ...