ECRI Announces 2025 Healthcare Supply Chain Excellence Award Winners
Twelve US health systems receive ECRI’s top honor for excellence in supply chain practices.
Category: Standards
Standards
Latest
Standards
Latest
2026 Healthcare Cybersecurity Benchmarking Study Opens for Enrollment
The study aims to provide benchmarks to help organizations prioritize investments and strengthen resilience against cyberattacks.
Standards
Latest
Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk
The devices may have cracks that could lead to patient rebreathing of exhaled gases.
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FDA Issues Class I Recall for Ambu Manual Resuscitators
The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.
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FDA Announces Class I Recall for ICU Medical Infusion Pump
A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
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Hamilton Medical Corrects C6 Ventilators Over Circuit Board Defect
The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.
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AdvaMed Urges CMS to Revise Proposed DME Competitive Bidding Rule
The medtech association cites risks to patient safety, reduced competition, and potential cost increases if the rule is implemented as is.
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Federal Court Bars Johnson & Johnson Unit from Blocking Device Reprocessing
The permanent injunction prohibits Biosense Webster from using ‘kill switches’ and tying clinical support to new device purchases, a practice the court found blocked hospital access to lower-cost reprocessed cardiac catheters.
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New Hospital Visitor System Features ‘Always-On’ Offline Capability
Managed from an Apple iPad, the system is designed to maintain visitor check-in, logging, and badge printing functions even during internet or power outages.
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AdvaMed, Industry Groups Push for Faster Medicare Coverage of Breakthrough Devices
A coalition of 67 organizations is urging the Centers for Medicare and Medicaid Services to address a multi-year delay between FDA authorization and reimbursement for new medical technologies.
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How Gaps in Requirements Traceability Fuel Recalls and Injuries
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
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FDA Clears Updated Hermia Voxel Dosimetry Software
The new release adds machine learning–based organ segmentation, faster dose calculations, and automated workflow features.
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Illumina to Pay $9.8M Over Cybersecurity Vulnerabilities in Genomic Sequencing Systems
Illumina has agreed to pay $9.8 million after allegations that its genomic sequencing systems sold to federal agencies contained cybersecurity vulnerabilities.
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FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound
The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.
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