FDA Seeks Industry Input on Autonomous and Remote-Operated Medical Robots
The FDA is seeking feedback on safety, cybersecurity, and oversight considerations for medical robots that operate autonomously or are controlled remotely.
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Joint Commission Updates Accreditation Survey Guides and Tools
The revisions include updated document review requirements, new construction and hyperbaric survey tools, and changes to building tour guidance.
Boston Scientific Restores Operations Following Cybersecurity Incident
Manufacturing, shipping, and cardiac device remote monitoring activations have resumed following the Aug 25 network disruption.
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Inside Siemens Healthineers’ $6.9M Medical Device Cybersecurity Research Project
The ARPA-H-funded research explores how AI and large-scale simulation could help hospitals prioritize cybersecurity remediation while maintaining continuity of care.
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The Next Healthcare Cyberattack May Start With a Trusted Vendor
Growing reliance on vendors, remote access, and connected technologies is expanding healthcare’s cyber risk and putting greater emphasis on third-party oversight and continuity planning.
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Inside a Medical Device Cyber Incident Response
A four-stage response framework shows how HTM, IT security, clinical leaders, and executives can coordinate when a cyber incident affects medical devices.
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FDA Clears Abbott Dual-Energy Cardiac Ablation Catheter
The TactiFlex Duo combines pulsed field ablation and radiofrequency energy in a single catheter for treating patients with atrial fibrillation.
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BMC Medical Recalls APAP Devices Over Firmware Defect That Can Halt Therapy
The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.
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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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