ECRI Urges Congress to Strengthen Oversight of Digital Health Tools
The patient safety organization highlights risks associated with unvalidated wellness devices and lack of transparency in clinical decision support software.
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Olympus Receives FDA Clearance for Open Surgery Sealing Device
The new Powerseal Open Extended Jaw device is the fourth addition to the company's advanced bipolar surgical energy portfolio.
FDA Clears New Device for Transseptal Heart Access
The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.
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AI in Diagnosis, Rural Care Gaps, and Preventable Diseases Lead ECRI’s 2026 Patient Safety Concerns
The annual report highlights risks tied to emerging technologies, access barriers, and workforce challenges that can contribute to preventable harm.
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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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