FDA Classifies Draeger VentStar Resus Neo Breathing Circuit Recall as Class I
Cracks in disposable infant breathing hoses could cause restricted ventilation, hypoxia, or death, prompting the agency's most serious recall designation.
Category: Standards
Standards
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Standards
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AAMI Backs Expanded Use of Consensus Standards Under MDUFA VI
The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
Standards
Latest
Boston Scientific Works Toward Restoring Operations Following Cybersecurity Incident
Boston Scientific reports no new unauthorized activity since Aug 25, while new cardiac device remote monitoring activations remain disrupted.
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Inside CHAI’s Push to Build Healthcare’s First Playbooks for Frontier AI Cyber Risk
A new work group is developing playbooks, expected by the end of the year, to help health systems respond to emerging AI cyber threats.
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FDA Issues Alert for Medtronic Esophageal Monitoring Devices
The agency warns of potential high-risk issues with Bravo CF delivery systems following reports of 184 serious injuries.
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FDA Issues Alert for Heart Pump Controllers Due to Component Failures
Abiomed is replacing components in Automated Impella Controllers following reports of injuries and deaths linked to purge cassette recognition issues.
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Boston Scientific Reports Network Outage Following Cybersecurity Incident
The company reports disruptions to business applications and its ability to process and ship customer orders.
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AI Is Speeding Up Both Sides of Hospital Cybersecurity
AI is helping attackers find and exploit weak spots faster. It’s also giving HTM and security teams new ways to strengthen their defenses.
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Six Months In, HHS Cyber Module Draws Steady Uptake From Health Systems
Since launching in March, the RISC 2.0 cybersecurity module has helped hundreds of facilities benchmark their defenses—and revealed where healthcare still falls short.
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FDA Clears Wearable Platform for Parkinson’s Symptom Monitoring
The system uses clinical-grade wearables and algorithms to provide objective data on tremors, sleep, and medication compliance.
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FDA Issues Alert for GE HealthCare Patient Monitoring Software Issue
The issue involves the Portrait Mobile Monitoring Solution and could lead to patients being removed from the system or alarm settings resetting during updates.
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You Can’t Patch Everything, So Own the List That Decides What Gets Fixed First
Hospitals can’t address every medical device vulnerability at once, making clear ownership of the priority list—and HTM’s role in shaping it—critical.
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FDA Issues Early Alert for Becton Dickinson Convenience Kits
Certain procedure trays contain recalled sodium chloride ampules that may pose a risk of infection or organ failure.
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FDA Seeks Input on Generative AI Medical Device Regulation
The agency released a discussion paper to address the unique risks and potential of generative artificial intelligence in the healthcare ecosystem.
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