FDA Clears YorLabs Intracardiac Imaging System
The no-capital-expenditure ultrasound platform is designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.
Category: Standards
Standards
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Standards
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Joint Commission Names Inaugural Recipient of the 2025 Healthcare Innovation Award
Tampa General Hospital is honored for integrating new strategies and technologies to improve patient safety and care quality.
Standards
Latest
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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CISA Issues Draft Guide for Software Bill of Materials
The updated voluntary guidance reflects the evolution of SBOM practices and aims to help organizations better manage software supply chain risks.
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Federal Wheelchair Right to Repair Act Introduced in Congress
The proposed legislation would require manufacturers to provide parts, documentation, and tools, following similar laws passed in four states.
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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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