FDA Issues Safety Guidelines for Charging Medical Devices to Prevent Overheating
The agency recommendations emphasize using manufacturer-authorized accessories and avoiding overnight charging to reduce fire and injury risks.
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Texas Directs Healthcare Facilities to Align With FDA Medical Device Cybersecurity Guidance
State officials are urging hospitals to review device cybersecurity risks and align policies with FDA guidance.
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FDA to Accept De-identified Data for Certain Medical Devices Submissions
New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.Â
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FDA Issues Safety Guidelines for Charging Medical Devices to Prevent Overheating
The agency recommendations emphasize using manufacturer-authorized accessories and avoiding overnight charging to reduce fire and injury risks.
Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
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FDA Warns of Injuries and Deaths Linked to Hyperbaric Oxygen Therapy
The agency reminds healthcare facilities to follow manufacturer instructions for use and maintenance after reports of fires, serious injuries, and deaths.
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GE HealthCare Leads FDA AI Device Clearances for Fourth Consecutive Year
The company has now accumulated over 100 authorizations for artificial intelligence in its medical technology portfolio.
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FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
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MDUFA VI Process Officially Begins With FDA Public Meeting
AdvaMed leaders call for a continued focus on timely patient access and regulatory predictability as the FDA opens discussions on the next medical device user fee agreement.
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Philips Receives FDA Clearance for Image-Guided Prostate Cancer Solution
The newly cleared platform combines MR and ultrasound imaging to support real-time guidance for focal therapy and improve clinical accuracy.
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Strengthening Industry-Government Relationships Amid Leadership Transitions
Advocacy built on long-term relationships can help HTM professionals stay influential as agency leaders and lawmakers change.
