FDA Issues Safety Guidelines for Charging Medical Devices to Prevent Overheating
The agency recommendations emphasize using manufacturer-authorized accessories and avoiding overnight charging to reduce fire and injury risks.
Category: Standards
Standards
Latest
Standards
Latest
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.
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.
Read More
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.
Read More
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.
Read More
Boston Scientific Receives FDA Clearance for Asurys Fluid Management System
Device is designed to regulate irrigation and intrarenal pressure during endoscopic urologic procedures
Read More
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.
Read More
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.
Read More
Could Vermont Crack the Code on Right to Repair? (Editor’s Message)
A recent hearing in Vermont shows lawmakers are asking more pointed questions about medical device repair. What happens next may depend on whether HTM professionals speak up.
Read More
GE HealthCare’s Photonova Spectra Photon-counting CT Receives FDA Clearance
The cleared system introduces photon-counting CT designed to capture spectral data in a single scan and reduce protocol complexity.
Read More
Defibrillation Lead Wins FDA Approval for Conduction System Pacing
The defibrillation lead, approved for placement in the left bundle branch area, can deliver both life-saving shock therapy and physiologic pacing through the heart’s natural electrical system.
Read More
CISA Issues Alert on Endpoint Management System Security After Stryker Cyberattack
Federal agency calls on healthcare and medical technology organizations to tighten endpoint management controls following attack on Stryker’s Microsoft environment.
Read More
EPA Proposes Rolling Back Ethylene Oxide Emission Rules Tied to Medical Device Sterilization
The proposed amendments target Biden-era standards the agency says threatened the domestic supply of sterilized medical equipment used across health care settings.
Read More
Do CE/HTM Professionals Lack Empathy?
Why empathy may not be the issue—and what’s actually behind communication gaps in HTM.
Read More