Baxter Identifies Cybersecurity Incident Involving Third-Party Applications
The company reports no impact on manufacturing, patient services, or medical technology safety.
Category: Standards
Standards
Latest
Standards
Latest
Bipartisan Bill Aims to Strengthen Cybersecurity for Rural Hospitals
The Rural Hospital Cybersecurity Enhancement Act would require the Department of Health and Human Services to develop workforce strategies and training resources for rural facilities.
Masimo Receives FDA Clearance for Opioid-Induced Respiratory Depression Detection Feature
The new capability for the Radius VSM wearable monitor uses pattern-recognition technology to analyze continuous patient data and help clinicians identify early signs of opioid-related respiratory risk.
Read More
FDA Clears New Software for Draeger Evita V800 Ventilator
The update introduces features designed to assist clinicians in managing patients with pulmonary diseases like acute respiratory distress syndrome.
Read More
Medline Facility Fire Highlights Healthcare Supply Chain Vulnerabilities, Staritas Says
The healthcare analytics firm emphasizes the importance of prep-work and functional equivalents before supply disruptions occur.
Read More
Safe Repair Requires Access, Not Monopoly
In a response to a recent right-to-repair op-ed, representatives of the American College of Clinical Engineering argue that giving qualified technicians access to service information, parts, and diagnostic tools can improve equipment uptime, reduce costs, and support patient care.
Read More
US Copyright Office Opens Petitions for DMCA Exemptions
The tenth triennial proceeding allows stakeholders to seek renewals or new exemptions for bypassing technological measures that control access to protected works.
Read More
FDA Issues Warning Letter to Zoll Medical Over Quality System Violations
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
Read More
CMS Establishes New Office to Lead Health Technology and Product Strategy
The Office of Health Technology and Products will oversee digital modernization, data exchange, and artificial intelligence initiatives across federal health programs.
Read More
Medtronic Receives FDA Clearance for Pulse Oximetry System
The new technology is designed to improve oxygen saturation monitoring reliability across diverse skin tones and patient populations.
Read More
Siemens Healthineers Awarded $6.9 Million for Medical Device Cybersecurity Research
The project focuses on using artificial intelligence to automate security updates and protect hospital equipment from cyberattacks.
Read More
FDA to Exempt Several Unclassified Medical Devices from Premarket Notification
New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.
Read More
FDA Clears 3D Imaging Platform for Existing Surgical C-Arms
The CBeam system enables 3D visualization using existing hospital infrastructure during orthopedic and neurological procedures.
Read More
FDA Clears New AI Tool for Cardiac Ultrasound Assessments
The tool from Clarius Mobile Health automates heart function measurements to assist clinicians in primary care and emergency settings.
Read More