Advanced Global Health Starts with Safe Medical Device Repairs
A HIMSS Foundation executive argues that expanding right-to-repair policies to healthcare could create patient safety and cybersecurity risks tied to medical device repair.
Category: Standards
Standards
Latest
Standards
Latest
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.
FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits
The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.
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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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