All

Unanimous Committee Vote Shows Medical Right to Repair Is Surging

In a landmark victory, California’s Senate Health Committee unanimously advanced SB 605, the Medical Device Right to Repair Act, by a 10-0, bipartisan vote.

All

Medtronic Partners with Cybersecurity Startup Sternum to Protect Its Pacemakers from Hackers

Medical device manufacturer Medtronic has forged a partnership with Internet of Things cybersecurity company Sternum after previously receiving flack about the hackability of its pacemakers.

All

COVID-19 Patient Dies in Hospital After Roommate Unplugs Ventilator

An elderly COVID-19 patient at Erithros Stavros (Red Cross) Public Hospital in Athens, Greece, died on Thursday, April 8, after his roommate disconnected his ventilator.

Medical Equipment

UL Achieves FDA ASCA Accreditation for Medical Device Testing

Global safety science company UL has received designation as an accredited ISO/IEC 17025 laboratory under the U.S. FDA Accreditation Scheme for Conformity Assessment, a voluntary pilot program for medical device safety and performance testing.

Testing & Calibration

Rigel Biomedical Test Technology Boosts Hermed Spain Expansion Plans

Hermed Spain’s team of biomedical service engineers and technicians has grown from 35 to 50 and all are equipped with the latest Rigel Medical test technology.

Imaging Equipment

FDA OKs New GE Healthcare 3D Surgical Imaging System

Waukesha, Wis.-based GE Healthcare announces 510(k) clearance from U.S. FDA for OEC 3D, a new surgical imaging system capable of 3D and 2D imaging.

Professional Development

nanoComposix Completes ISO 13485:2016 Certification for Quality Management System

San Diego-based nanoComposix announces the expansion of its quality management system to include ISO 13485:2016 certification.

Maintenance Strategies

The Joint Commission Issues Sentinel Event Alert on Optimizing Medication Safety with Smart Infusion Pumps

The alert provides recommended safety actions healthcare organizations can take to reduce the risks of errors caused by the misuse of smart infusion pumps.

Standards

Medtronic Stent Graft Recall Is Serious

Medtronic has recalled the Valiant Navion thoracic stent graft system due to stent fractures and endoleak concerns. But the FDA has categorized the recall as Class 1, the most critical kind.