Regulatory Rollercoaster: CGM Software Bug, Umbilical Sheets, & AI Analyzer
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SYNAPTIC DIGEST
Tuesday, December 30, 2025 • ⏱ 5-MIN READ
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Dexcom's CGM app bug requires an urgent update to avoid potential hyperglycemic events or death. |
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A novel umbilical cord-derived sheet device received FDA 510(k) clearance for wound care. |
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An AI-driven blood cell morphology analyzer gains manufacturing approval, promising improved efficiency. |
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This week's digest highlights the constant interplay between innovation and regulation, from software glitches in established devices to groundbreaking approvals for cutting-edge technologies. The medical device landscape is always changing.
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180 Days
Deadline for manufacturers to submit recall notifications using the new electronic format for medical device recalls outlined in H.R. 6594. This timeline is triggered after the system is implemented.
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$6.7 Million
Funding authorized by H.R. 6594 for the implementation of an electronic recall notification system for medical devices, specifically for fiscal year 2026. This funding is meant to ensure patient safety and improve the recall process.
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2 Business Days
The Secretary of Health and Human Services is required to conduct an initial review of recall notifications within this timeframe. This is a critical step in the new electronic notification process.
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✦ THE MAIN STORY
Dexcom G6 Software Bug Requires Urgent Update to Prevent Adverse Events
The Gist:
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A critical software bug in the Dexcom G6 and G6 Pro Android US CGM App (version 1.15.0) can cause the app to unexpectedly terminate. |
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The bug may lead to the user not receiving estimated glucose values, alarms, or alerts, potentially resulting in missed detection of high or low blood sugar events. |
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Dexcom is urging all users of the affected app version to upgrade immediately to prevent serious adverse health consequences, including death. |
The Challenge:
The FDA has issued a Class II recall for the Dexcom G6 and G6 Pro Android US CGM App version 1.15.0 due to a software bug. This bug causes the app to terminate unexpectedly. If the app crashes, users might not receive critical glucose readings, alarms, or alerts. The potential result is a missed detection of hyperglycemia or hypoglycemia. The company is asking all affected users to update the app. This correction is a critical update for anyone with this system.
The Solution:
Users must upgrade from app version 1.15.0 as soon as possible. The steps to upgrade include opening the App Store, searching for the Dexcom G6 app, installing the latest version, and opening the updated app. The FDA is taking this recall very seriously. See the FDA notice here.
Why This Matters:
This software correction underscores the critical need for rigorous testing and rapid response in medical device software development. For software engineers, it highlights the importance of incorporating automated testing and continuous monitoring into the development lifecycle. The software failure could lead to life-threatening scenarios. It impacts user trust and device safety. This emphasizes the need for rapid deployment and communication protocols to notify users of critical updates and avoid patient harm.
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✦ THE SECOND TAKE
StimLabs Launches First Umbilical Cord-Derived Sheet Device
The Gist:
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StimLabs has received FDA 510(k) clearance for Theracor, the first human umbilical cord–derived medical device sheet formulation for wound care. |
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The sheet formulation offers an alternative delivery format for clinicians requiring continuous wound coverage. |
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Theracor is indicated for similar wound types as the particulate format, including partial- and full-thickness wounds, pressure ulcers, and diabetic ulcers. |
The Technical Breakdown:
StimLabs has obtained 510(k) clearance for its novel sheet formulation of Theracor, a medical device derived from human umbilical cord extracellular matrix (ECM). The new device is designed to cover and protect wounds while maintaining a moist wound environment, offering a new format for clinicians managing acute and chronic wounds. The Theracor sheet formulation is intended to be used on the same types of wounds as its particulate counterpart, Corplex P, which was previously cleared by the FDA. The clearance of Theracor reflects the expanding portfolio of FDA-cleared umbilical cord–derived medical devices. The device is now available to clinicians as an option for wound management. Read more about the FDA clearance.
Why This Matters:
The clearance of Theracor represents an important development for design and manufacturing engineers. The creation of a sheet formulation device will likely require engineers to develop new processes. It expands the options for clinical application of human tissue-based solutions, providing greater flexibility for wound care providers. This advances innovation in the biomaterials space, where engineers are constantly seeking to optimize tissue regeneration and integration.
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INDUSTRY BRIEFING
WORK Medical AI Analyzer Gains Approval
The Gist:
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WORK Medical Technology Group's subsidiary, Hunan Saitumofei Co., Ltd., received manufacturing approval for its AI-Automated Human Blood Cell Morphology Analyzer. |
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The Class II medical device combines AI, high-speed digital imaging, and deep-learning algorithms. |
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Manufacturing is scheduled to begin in the first half of 2026, promising improved efficiency. |
The Technical Take:
WORK Medical Technology Group's AI-Automated Human Blood Cell Morphology Analyzer has received regulatory manufacturing approval. The analyzer combines optical imaging, a sample-handling module, a barcode scanner, and AI analysis software. The device automates cell morphology screening and quantifies parameters of red blood cells and platelets. The device is expected to improve diagnostic efficiency and reduce costs. Read more on the approval here.
H.R. 6594 Aims to Improve Medical Device Recalls
The Gist:
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The Medical Device Recall Improvement Act of 2025 (H.R. 6594) aims to improve the recall notification process by establishing an electronic system. |
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Manufacturers and importers will be required to submit recall notifications electronically, with specific content requirements. |
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The bill authorizes funding and adds penalties for non-compliance. |
The Technical Take:
The bill mandates the creation of a standardized electronic format for medical device recall notifications within two years of enactment. The required information includes manufacturer details, the reason for the recall, UDI information, and patient/healthcare professional information. This update will require manufacturers to adjust their recall processes and data management systems to comply with the new electronic notification format. Learn more about the bill.
Philips Explores AI and Ecosystem Growth
The Gist:
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Philips is expanding its Connected Care business through strategic partnerships and AI integration. |
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The company is moving towards 'as a service' models, with a focus on software and services. |
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AI is being used to improve efficiency, productivity, and workflows within the company. |
The Technical Take:
Philips is focusing on building out its Connected Care ecosystem. The company is using partnerships to boost its software-driven organization. The company uses AI for both internal operations and within its care delivery paradigm. Philips is also moving towards 'as a service' models to support health systems. Read more about Philips' plans here.
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💬 Got thoughts on this week's stories?
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"May your tolerances be tight and your CAPAs be few."
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