Category: Standards

Standards

Ransomware Now Top Driver of Patient Data Breaches, Study Finds

A new study shows ransomware attacks accounted for 69% of all patient records compromised in 2024.

Standards

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

The FDA is ramping up unannounced inspections at foreign sites producing medical products and other goods to align regulatory oversight with domestic standards.

Standards

Right to Repair Legislation Now Filed in All 50 States

With Wisconsin filing its first Right to Repair bill, all 50 states have now considered the legislation over the past eight years.

Servicing Legislation

IAMERS Calls for Legal Protections on Hospitals’ Right to Repair Medical Devices

The International Association of Medical Equipment Remarketers and Servicers is calling for stronger legal protections to uphold hospitals’ ability to repair—and choose who repairs—their own medical devices.

FDA Updates

AI-Driven Coronary Physiology Software Gains FDA Clearance

The software, powered by artificial intelligence and deep learning, assesses angiography-derived coronary physiology in patients with ischemic coronary artery disease.

Government Regulations

AdvaMed Pushes for Zero-for-Zero Tariff Model in Medtech Trade

AdvaMed’s president says a reciprocal zero-for-zero tariff model would ensure fair competition and patient access.

Cybersecurity

NSA Guidance Targets OT Smart Controller Security

NSA publishes recommendations for smart controller security controls and technical requirements for OT environments.