AI System for Predictive Burn Wound Assessment Receives FDA De Novo Clearance
The system utilizes multispectral imaging and algorithms to help clinicians determine the healing potential of burn wounds.
Category: Standards
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Standards
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FDA OKs AI Early Warning System for Hospital Sepsis Detection
The technology, developed by Johns Hopkins University researchers, identifies sepsis cases up to 48 hours earlier than traditional methods and has reduced mortality rates by 18%.
CMS and FDA Launch RAPID Pathway to Speed Access to Breakthrough Medical Devices
The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
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Philips Receives FDA Clearance for Rembra CT Platform
Clearances for Rembra CT, Rembra RT, and Areta RT aim to enable high-throughput imaging at scale and elevate precision across the cancer care pathway.
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ECRI Spins Out Spend and Recall Management into New Company
Staritas, backed by investment from Accel-KKR, will focus on healthcare supply chain data and artificial intelligence solutions.
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FDA Clears Hybrid Heart Imaging System
The platform combines ultrasound and optical imaging to provide detailed views of coronary anatomy in a single workflow.
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FDA Clears Philips AI-Powered Spectral CT Imaging System
The system uses artificial intelligence for image reconstruction to improve diagnostic precision and workflow efficiency in radiology, cardiology, and oncology.
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Philips Issues Correction for Trilogy Evo Ventilators Following FDA Class I Recall
The Food and Drug Administration identifies the software update and nebulizer restrictions as the most serious type of recall.
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US and UK Regulators Strengthen Cooperation on Medical Device Approvals
The partnership between the Food and Drug Administration and the Medicines and Healthcare products Regulatory Agency aims to streamline technology access and reduce regulatory duplication.
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Why Cybersecurity Incident Response Planning Should Be a Top Priority in Health Care
Most hospitals don’t have a plan for when they get hit by a cyberattack—and that’s a problem they can fix before it costs them.
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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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