Category: Standards

Standards

LivaNova Recalls Blood Pump Device for Risk of Unintentional Extended Pump Stop

LivaNova is recalling the LifeSPARC Controller due to a software update being available to address a previous software malfunction.

Standards

Opticyte’s Patient Monitor for Organ Failure Earns Breakthrough Device Designation

Opticyte's Cell O₂ Patient Monitor has received Breakthrough Device Designation for the continuous monitoring of those at risk of organ failure.

Standards

5 Elements of a Comprehensive Cybersecurity Strategy

These elements are critical for a comprehensive cybersecurity defense strategy, including checklists to protect healthcare devices and data.

Servicing Legislation

New York Breaks the Right to Repair Bill as it’s Signed Into Law

New amendments made to New York’s Digital Fair Repair Act, prior to it being signed by the state’s Governor, provide new exceptions for OEMs.

FDA Updates

FDA OKs VERO Biotech’s Tankless Inhaled Nitric Oxide Delivery System

VERO Biotech announces that the U.S. FDA has approved the latest generation of its tankless inhaled nitric oxide delivery system.

Government Regulations

ECRI Names Monument Health Winner of 2022 Safety Excellence Award

Rapid City, S.D.-based Monument Health is recognized for exceeding organization-wide safety goals of reducing harm and errors by improving culture of safety and event reporting.

Cybersecurity

US Family Planning Nonprofit MFHS Says Patient Medical Data Stolen in Ransomware Attack

Maternal & Family Health Services experienced a sophisticated ransomware incident that may have exposed sensitive patient data.