The newly cleared contrast-enhanced mammography and biopsy capabilities aim to help radiologists characterize suspicious findings and perform targeted biopsies more efficiently.
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
The revision to the standard, effective June 1, 2026, specifies that annual electrical safety inspection by a certified electrician or biomedical engineer satisfies the equipment maintenance requirement for in-lab sleep testing programs.
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The ACIST Pro Diagnostic System provides automated contrast delivery to improve efficiency and safety in cardiac catheterization labs.
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Past equipment performance and maintenance experience can provide valuable feedback for future technology decisions while strengthening recognition of CE and HTM expertise.
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The new Artis portfolio features an AI-powered imaging chain designed to improve image quality and noise reduction during interventional procedures.
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The patient safety organization highlights risks associated with unvalidated wellness devices and lack of transparency in clinical decision support software.
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The technology, developed by Johns Hopkins University researchers, identifies sepsis cases up to 48 hours earlier than traditional methods and has reduced mortality rates by 18%.
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The updates include a new spleen exam workflow, compatibility with Apple laptops, and direct connection to electronic health records.
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The inaugural program recognizes excellence in patient safety and healthcare quality for organizations outside the US. Nominations are being accepted through June 8.
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The joint report addresses cybersecurity challenges for legacy infrastructure and physical safety requirements in facility and industrial systems.
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The system uses artificial intelligence to provide real-time guidance for brain biopsies, shunt placements, and other neurosurgical procedures.
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The agency recommendations emphasize using manufacturer-authorized accessories and avoiding overnight charging to reduce fire and injury risks.
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New research finds 24% of healthcare organizations report cyberattacks affecting medical devices, with 80% impacting patient care, as cybersecurity becomes a core requirement in medical device purchasing.
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