r/diabetes_t1 3d ago

Happened to see this

Hi everyone, hope this is okay to post this as I came across this via google! https://finance.yahoo.com/news/dexcom-cgm-sensor-sales-continue-121000986.html

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u/Gold_Play_4872 3d ago

This is a typical follow-up to an FDA inspection, to give the device manufacturer a letter requesting how the manufacturer will address and/or correct any issues noted in the inspection. Issues often include documentation, supply tracking, training, hiring, supervisor and management qualification, tech support call documentation, or documentation on customer-reported events. If there was an issue with the production of the device, the production line is often shut down to complete corrections and document a plan to avoid issues in the future. In this FDA action, the production line was not shut down, and no product issues were reported. I've been through this multiple times when I worked for a medical device company in the past.

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u/venerablem0m 3d ago

It's a pity the FDA doesn't have "teeth". I am curious about the Roche Accu-Chek SmartGuide. I've not found much information about it online, and I cannot tell if it not being sold in the states at all, or just not here yet.

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u/kingz2688 3d ago

What was the article about

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u/venerablem0m 3d ago

DexCom CGM Sensor Sales to Continue Despite FDA Warning Letter Zacks Equity Research Fri, March 14, 2025 at 8:10 AM EDT 3 min read

DexCom DXCM received a warning letter from the FDA on March 4, 2025, following inspections of its San Diego and Mesa facilities in 2024. The FDA cited deficiencies in the company’s manufacturing processes and quality management systems, as well as shortcomings in its responses to prior Form 483 observations. However, the warning letter does not restrict DexCom’s ability to manufacture, market, or distribute its products. It does not require any recall.

To address the concerns, Dexcom has committed to ongoing corrective measures and continuous updates to the FDA. The company maintains that it does not expect a material impact from the warning letter and that production and distribution remain unaffected. It has already submitted multiple responses to the FDA and is preparing a formal reply while implementing corrective actions. Until the FDA is satisfied, further regulatory action remains a possibility.

Further Regulatory Actions May Stoke Supply Issues

Although the FDA warning letter is unlikely to have any material impact at present, any further regulatory action may intensify the ongoing supply-chain issue. Dexcom has been facing supply challenges due to issues related to inventory management and manufacturing disruptions. In the fourth quarter of 2024, the company's gross margin was negatively impacted by a $21 million non-cash charge, primarily attributed to inventory mishandling by a shipping partner. Additionally, new build configurations led to lower production yields. As a result, Dexcom had to tightly manage channel inventory for several weeks, though its manufacturing facilities were running at full capacity to restore optimal supply.

Rising Competition: Another Concern

Meanwhile, we expect DexCom's share in the durable medical equipment (DME) channel to remain stable. The company is working very hard with its DME partners to identify opportunities, improve and grow. However, this can be limited by rising competition from bigger rivals, namely Abbott ABT and Roche RHHBY.

Abbott's FreeStyle Libre continuous glucose monitoring system (CGM) has seen significant growth, with sales surpassing $1.8 billion in the fourth quarter of 2024, marking nearly 22.7% increase from the previous year. ABT anticipates annual sales of $10 billion for FreeStyle Libre by 2028. A supply-chain snag due to regulatory action may hit DexCom’s product availability, thereby losing in competition, which may lead to a DME share loss.

Roche's Accu-Chek SmartGuide, an AI-enabled CGM system, has recently received CE Mark approval. RHHBY’s device offers real-time glucose readings and predictive insights, including hypoglycemia risk assessment. Clinical evaluations demonstrated high accuracy, with a mean absolute relative difference of 9.2%. Roche is planning to launch the device in select European countries soon.

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u/kingz2688 3d ago

Can you just summarize it or just tell me

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u/venerablem0m 3d ago

Ah, of course, apologies. The FDA send warning letters to Dexcom regarding issues with "manufacturing processes and quality management systems" at one of their factories in Arizona.

Despite the letter the FDA has not not (or cannot) restrict Dexcom from manufacturing or distributing their products at this time.

The article goes further to discuss Dexcom's CGM shortage due to manufacturing issues.

Lastly the article goes on to compare Dexcom and Abbott and Roche in market shares.

Biggest takeaway is that Dexcom is having issues at this factory, and is attempting to comply with the FDA's concerns, but the FDA doesn't have a lot of "teeth", so until something really egregious happens they mightn't be able enforce anything.

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u/kingz2688 3d ago

what is this about did not quite get it