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.
Category: Standards
Standards
Latest
Standards
Latest
Stryker Hit by Cyberattack Linked to Iran-Tied Hacking Group, Causing Global Network Outage
The attack, attributed to pro-Palestinian hacking group Handala, reportedly wiped Windows devices across Stryker's enterprise environment and disrupted ordering systems.
FDA Clears 3T Neonatal MRI System Designed for Use in the NICU
The system features a compact footprint and is designed for whole-body imaging in neonatal care settings.
Read More
FDA Updates Medical Device Cybersecurity Guidance to Address New Federal Requirements
Revised guidance aligns with quality management system regulation changes and provides recommendations for cyber device submissions under section 524B of the FD&C Act.
Read More
What 2025’s Healthcare Breaches Taught Us and Why 2026 Raises the Stakes
Lessons from 2025’s breaches point to a tougher reality in 2026, as AI adoption accelerates and cybersecurity becomes inseparable from patient care.
Read More
FDA Clears Mobile C-Arm System With AI-Enhanced Imaging
The mobile C-arm system features AI-powered imaging tools and cable-free design for interventional procedures.
Read More
AI Chatbots Top Annual List of Health Technology Hazards
ECRI’s report also sounds the alarm on insufficient planning for systems outages, substandard medical products, missed recalls of home diabetes management devices, and more.Â
Read More
GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals
The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.
Read More
FDA Clears Elekta’s AI-Powered CT-Linear Accelerator
Elekta’s Evo system combines CT-guided radiation therapy with AI-enhanced imaging designed to support visualization of tumors and nearby organs at risk during treatment.
Read More
FDA Clears Silicon Photonics System for Lung Biopsy Procedures
The system integrates depth imaging technology directly into biopsy tools to improve tissue sampling accuracy during bronchoscopy.
Read More
FDA Clears Multi-Modality Breast Biopsy and Tissue Removal System
The newly cleared system is designed to support breast biopsy procedures across multiple imaging modalities using a single platform.
Read More
24×7 Appoints Medical Device Cybersecurity Expert to Advisory Board
The cybersecurity veteran joins 24×7’s advisory board as cyber resilience becomes a growing focus for the HTM field.
Read More
Fresenius Kabi Removes Ivenix Large-Volume PumpsÂ
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
Read More
Baxter Removes Sigma Spectrum Infusion System Platforms
The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.
Read More