FDA Clears AI Tool for Coronary Plaque Analysis
The clearance enables on-premise AI analysis of coronary CT angiography for quantifying calcified and non-calcified plaque.
Category: Standards
Standards
Latest
Standards
Latest
US Indicts Suspect in Ransomware Campaigns That Disrupted Healthcare Systems
The US Department of State is offering up to $11 million for information leading to the arrest of Volodymyr Tymoshchuk, accused of deploying ransomware that targeted hospitals, companies, and major industrial firms
Standards
Latest
US and Global Agencies Release ‘Shared Vision’ of Software Bill of Materials for Cybersecurity
The guidance promotes the use of a Software Bill of Materials to increase transparency in the software supply chain, impacting medical device security and vulnerability management.
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The Cybersecurity Threat Lurking in Legacy Medical Devices
Why HTM teams must treat “old but working” as a high-stakes cyber risk—and how to protect patients and operations now.
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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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