AdvaMed Releases White Paper on Medical Imaging CybersecurityÂ
The document outlines common imaging device outage scenarios and manufacturers’ recommended steps to mitigate the impact and keep systems functioning. Â
Category: Standards
Standards
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Standards
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Court Upholds DMCA Repair Exemption for Medical Devices
A US District Court has upheld a rule allowing limited circumvention of copyright protections for the repair and maintenance of medical devices.
Standards
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Joint Commission Teams with CHAI to Set National AI Guidance
The Joint Commission and the Coalition for Health AI will co-develop guidance and certification to support AI integration across US healthcare organizations.
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New Report Flags Gaps in Right to Repair Compliance
Nearly half of reviewed products lacked accessible repair manuals, and 44% had no spare parts available, according to a new report from US PIRG.
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FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound
Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.
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On the Front Lines of a New Era in Disaster Response
With disasters on the rise, HTM teams are relying on modern tools and coordinated planning to support smarter emergency response.
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Joint Commission Unveils Major Accreditation Overhaul
In its most significant overhaul since 1965, the Joint Commission has eliminated more than 700 requirements in a new model designed to reduce burden, align with how care is delivered today, and drive better patient outcomes.
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FDA Finalizes Medical Device Cybersecurity Premarket Guidance
The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.
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Prisma Health Wins 2025 ECRI Award for Health Technology Excellence
The health system’s multi-year effort to strengthen network design, improve workflows, and prepare for outages earned recognition following its performance during Hurricane Helene.
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FDA Releases White Paper on Cybersecurity in Medical Manufacturing
New white paper highlights the need to secure operational technologies used in medical product production.
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FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns
Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.
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ECRI Launches Free AI Resource Hub to Support Safe Implementation in Healthcare
ECRI has published a collection of resources that can help healthcare leaders safely integrate artificial intelligence (AI) solutions into care delivery.
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Medtronic Recalls Certain Newport Ventilators and Related Service Parts
Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.
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Zyno Medical Recalls Infusion Pumps Over Software Issue
Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.
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