Category: Standards

Standards

FDA Tightens Cybersecurity Regulations for Medical Devices

The FDA now mandates that medical device manufacturers include a SBOM for cybersecurity compliance under FD&C Act.

Standards

Teleflex Recalls Certain Arrow Catheterization Kits

Teleflex is recalling the Arrow QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits after reports of issues.

Standards

ICU Medical Infusion Pump, Software Nab FDA Clearance

ICU Medical Inc. announces that it has received U.S. Food and Drug Administration 510(k) regulatory clearance for the Plum Duo infusion pump with LifeShield infusion safety software. The products will be available in early 2024.

Servicing Legislation

AdvaMed, Opponents Spar About FTC Right to Repair Rulemaking

In what could be viewed as a controversial stance in the HTM field, AdvaMed submitted comments to the Federal Trade Commission (FTC), expressing concern at a proposed rule-making in favor of national “right to repair” standard. Their opponents hold a vastly different view.

FDA Updates

FDA Seeks Public Comment on Premarket Cybersecurity Guidance

The FDA has developed a draft guidance for updates to its Premarket Cybersecurity Guidance and is seeking public comment.

Government Regulations

Hackensack Hospitals Meet Sustainable Healthcare Certification

Four Hackensack Meridian Health hospitals have achieved The Joint Commission’s Sustainable Healthcare Certification (SHC).

Cybersecurity

Claroty Report Reveals Healthcare’s Cybersecurity Vulnerabilities

Claroty’s latest report highlights alarming security issues in medical devices connected to healthcare networks, revealing that 63% of tracked vulnerabilities are exploited, with 23% of devices affected.