FDA Clears Updated Hermia Voxel Dosimetry Software
The new release adds machine learning–based organ segmentation, faster dose calculations, and automated workflow features.
Category: Standards
Standards
Latest
Standards
Latest
Pros and Cons of Single-Use Versus Reprocessed Medical Devices
ECRI research examines safety, cost, and environmental tradeoffs of reusing versus discarding medical devices in hospitals.
Standards
Latest
HL7 Launches AI Office to Develop Standards for Artificial Intelligence in Healthcare
New initiative aims to create global standards for transparent, interoperable, and safe AI in clinical and operational settings.
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AMMA, AdvaMed Back Key Measures in ‘One Big Beautiful Bill’
The bill, signed into law on July 4, includes tax, trade, and investment provisions that industry groups say will support domestic manufacturing and medtech innovation.
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Medical Device Cyberattacks Hit 22% of Healthcare Orgs, Disrupting Patient Care in Majority of Cases
A new report shows that security concerns shift from IT systems to operational technology.
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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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