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Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 
• By Brian Bossetta

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

Dexcom has updated a May recall of multiple continuous glucose monitoring (CGM) units due to an alarm malfunction in the receivers.

The problem affects the Dexcom G6, G7, ONE and ONE+ models and impacts more than 700,000 units.

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What Do Money, Gender, And Politics Have To Do With Device Recalls? Quite A Lot

 
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During the MDIC Excellence in Quality Summit, an expert in product recalls offered several unconventional and somewhat controversial factors that impact how quickly device makers initiate a recall once they discover a problem.

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US FDA inspections of three Philips manufacturing sites earlier this year resulted in a September warning letter that claimed the company was not in conformity with current good manufacturing practices. Philips says it is addressing the agency’s concerns and working to enhance its quality systems.

US FDA Plans Move Inspectorate Back To More Generalist Organization

 
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The “Simple Reform” initiative would reverse a 2017 move to ensure FDA investigators were experts in the commodity they inspected or in clinical research regulations.

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Could Oura Take A Bite Out Of Apple? Company Seeks FDA Clearance For Blood Pressure Feature

 
• By Brian Bossetta

Wearables innovator Oura has launched a profile study aimed at helping the company secure FDA clearance for a blood pressure feature for its smart ring. Study participants will answer questions while wearing the ring, which the company plans to use to support the feature’s efficacy.

Medicare’s TCET Pathway Wins Acclaim From Early Users, Even As ‘Messy Middle’ Persists

 
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Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.

AdvaMed Warns Of Challenges With Remote Devices While Noting Their Potential

 
• By Brian Bossetta

Though the advance of remote medical device technology allows for better at-home care, it comes with challenges and risks, says AdvaMed, which has published a safety bulletin guiding stakeholders on the operation of remote devices.