FDA Clears New Features for Portable Liver and Spleen Ultrasound System
The updates include a new spleen exam workflow, compatibility with Apple laptops, and direct connection to electronic health records.
Category: Standards
Standards
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Standards
Latest
FDA Clears Avatar Medical Vision for 3D Imaging and Surgical Planning
The software supports CT and MR image visualization across standard displays, glasses-free 3D systems, and virtual reality environments.
Standards
Latest
FDA Clears Wireless Maternal-Fetal Monitoring Platform
The wearable sensor system provides continuous, simultaneous monitoring of maternal and fetal vital signs to improve clinical evaluation.
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Federal Agencies Warn of Cyberattacks Targeting Programmable Logic Controllers
Iranian-affiliated actors are exploiting internet-facing operational technology devices, leading to operational disruptions and financial losses across US infrastructure.
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Social Engineering Drives 88% of Healthcare Cybersecurity Losses
A new report finds that average cyber insurance claim severity in the healthcare sector exceeded $2 million per incident in 2025.
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Texas Directs Healthcare Facilities to Align With FDA Medical Device Cybersecurity Guidance
State officials are urging hospitals to review device cybersecurity risks and align policies with FDA guidance.
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FDA Clears Deep Learning Technology for High-Resolution CT Imaging
The software is designed to enhance spatial resolution and suppress artifacts in pulmonary, musculoskeletal, and inner ear scans.
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Restore Robotics Receives FDA Clearance for Additional Remanufactured da Vinci Xi Instruments
Clearances expand options for hospitals seeking lower-cost alternatives to OEM robotic surgical instruments.
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FDA Clears Medtronic Surgical System for Cranial and ENT Procedures
The platform combines planning, navigation, and robotics, with AI-enabled features for imaging and workflow support.
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Boston Scientific Receives FDA Clearance for Asurys Fluid Management System
Device is designed to regulate irrigation and intrarenal pressure during endoscopic urologic procedures
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Philips Receives FDA Clearance for AI Software to Guide Mitral Valve Repair
EchoNavigator with DeviceGuide uses AI to track and visualize repair devices in real time during minimally invasive procedures.
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MARS Bioimaging Gains FDA Clearance for Portable Photon-Counting CT Scanner
The extremity-focused system is designed for point-of-care use, including clinics and ambulatory settings.
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Could Vermont Crack the Code on Right to Repair? (Editor’s Message)
A recent hearing in Vermont shows lawmakers are asking more pointed questions about medical device repair. What happens next may depend on whether HTM professionals speak up.
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GE HealthCare’s Photonova Spectra Photon-counting CT Receives FDA Clearance
The cleared system introduces photon-counting CT designed to capture spectral data in a single scan and reduce protocol complexity.
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