Nova Biomedical Pulls StatStrip Gen 2.0 Glucose Meters Over Patient ID Errors
A software issue can cause glucose results to be assigned to the wrong patient's medical record. One serious injury has been reported, and a fix is expected in November.
Category: Standards
Standards
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Standards
Latest
Joint Commission President and CEO Announces Retirement
The organization’s president and CEO will retire at the end of 2026, with its current chief operating officer appointed to take over the role in January.
FDA Classifies GE HealthCare Patient Monitoring Software Correction as Class II Recall
The agency also clarified its description of the Portrait Core Services software issue, which can result in patients being removed from monitoring or alarm settings resetting during software updates.
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Hospital AI Adoption Is Outpacing Cybersecurity Protections, Report Warns
Black Book Research identifies major security gaps as healthcare facilities deploy autonomous tools and models without proper safeguards.
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Framework Addresses Cybersecurity and Maintenance for Legacy Ultrasound Systems
An analysis finds nine in 10 cleared ultrasound system designs predate the US cyber-device statute—and all four CISA advisories naming ultrasound lines had incomplete patch coverage.
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Cybersecurity Enters the Buying Cycle
Cybersecurity considerations are coming earlier in medical device purchasing as HTM teams look more closely at vendor support, contract terms, and long-term security risks.
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Boston Scientific Works Toward Restoring Operations Following Cybersecurity Incident
Boston Scientific reports no new unauthorized activity since Aug 25, while new cardiac device remote monitoring activations remain disrupted.
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Inside CHAI’s Push to Build Healthcare’s First Playbooks for Frontier AI Cyber Risk
A new work group is developing playbooks, expected by the end of the year, to help health systems respond to emerging AI cyber threats.
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FDA Issues Alert for Medtronic Esophageal Monitoring Devices
The agency warns of potential high-risk issues with Bravo CF delivery systems following reports of 184 serious injuries.
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FDA Issues Alert for Heart Pump Controllers Due to Component Failures
Abiomed is replacing components in Automated Impella Controllers following reports of injuries and deaths linked to purge cassette recognition issues.
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Boston Scientific Reports Network Outage Following Cybersecurity Incident
The company reports disruptions to business applications and its ability to process and ship customer orders.
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AI Is Speeding Up Both Sides of Hospital Cybersecurity
AI is helping attackers find and exploit weak spots faster. It’s also giving HTM and security teams new ways to strengthen their defenses.
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Six Months In, HHS Cyber Module Draws Steady Uptake From Health Systems
Since launching in March, the RISC 2.0 cybersecurity module has helped hundreds of facilities benchmark their defenses—and revealed where healthcare still falls short.
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FDA Clears Wearable Platform for Parkinson’s Symptom Monitoring
The system uses clinical-grade wearables and algorithms to provide objective data on tremors, sleep, and medication compliance.
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