FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
Category: Standards
Standards
Latest
Standards
Latest
Strengthening Industry-Government Relationships Amid Leadership Transitions
Advocacy built on long-term relationships can help HTM professionals stay influential as agency leaders and lawmakers change.
New Report Flags Gaps in Right to Repair Compliance
Nearly half of reviewed products lacked accessible repair manuals, and 44% had no spare parts available, according to a new report from US PIRG.
Read More
FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound
Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.
Read More
On the Front Lines of a New Era in Disaster Response
With disasters on the rise, HTM teams are relying on modern tools and coordinated planning to support smarter emergency response.
Read More
Joint Commission Unveils Major Accreditation Overhaul
In its most significant overhaul since 1965, the Joint Commission has eliminated more than 700 requirements in a new model designed to reduce burden, align with how care is delivered today, and drive better patient outcomes.
Read More
FDA Finalizes Medical Device Cybersecurity Premarket Guidance
The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.
Read More
Prisma Health Wins 2025 ECRI Award for Health Technology Excellence
The health system’s multi-year effort to strengthen network design, improve workflows, and prepare for outages earned recognition following its performance during Hurricane Helene.
Read More
FDA Releases White Paper on Cybersecurity in Medical Manufacturing
New white paper highlights the need to secure operational technologies used in medical product production.
Read More
FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns
Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.
Read More
ECRI Launches Free AI Resource Hub to Support Safe Implementation in Healthcare
ECRI has published a collection of resources that can help healthcare leaders safely integrate artificial intelligence (AI) solutions into care delivery.
Read More
Medtronic Recalls Certain Newport Ventilators and Related Service Parts
Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.
Read More
Zyno Medical Recalls Infusion Pumps Over Software Issue
Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.
Read More
Advocate Health, Joint Commission Partner on Systemwide Accreditation Initiative
The initiative aims to enhance patient safety, care quality, and performance consistency across 69 hospitals.
Read More