The new capability for the Radius VSM wearable monitor uses pattern-recognition technology to analyze continuous patient data and help clinicians identify early signs of opioid-related respiratory risk.
New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.
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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A new report identifies healthcare as a top-risk sector for data breaches and ransomware, with human error involved in most breaches.
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The new Powerseal Open Extended Jaw device is the fourth addition to the company’s advanced bipolar surgical energy portfolio.
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The Ultreon 3.0 software uses optical coherence tomography and artificial intelligence to guide physicians during procedures to open blocked arteries.
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The software supports CT and MR image visualization across standard displays, glasses-free 3D systems, and virtual reality environments.
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