Standards

MDUFA VI Process Officially Begins With FDA Public Meeting

AdvaMed leaders call for a continued focus on timely patient access and regulatory predictability as the FDA opens discussions on the next medical device user fee agreement.

Standards

Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks

A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.

Standards

Disconnection Hazard Prompts Recall of AirLife Infant Ventilation Circuits

Jul 11, 2025

Bipartisan Bill Would Expand Military’s Right to Repair Equipment

Jul 9, 2025

HL7 Launches AI Office to Develop Standards for Artificial Intelligence in Healthcare

Jul 9, 2025

AMMA, AdvaMed Back Key Measures in ‘One Big Beautiful Bill’

Jul 7, 2025

Medical Device Cyberattacks Hit 22% of Healthcare Orgs, Disrupting Patient Care in Ma...

Jul 2, 2025

Joint Commission Teams with CHAI to Set National AI Guidance

Jul 2, 2025

New Report Flags Gaps in Right to Repair Compliance

Jul 2, 2025

FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound

Jul 1, 2025

On the Front Lines of a New Era in Disaster Response

Jun 30, 2025 | Hospital Safety | 0 |

With disasters on the rise, HTM teams are relying on modern tools and coordinated planning to support smarter emergency response.

Joint Commission Unveils Major Accreditation Overhaul

Jun 30, 2025 | Joint Commission | 0 |

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.

FDA Finalizes Medical Device Cybersecurity Premarket Guidance

Jun 27, 2025 | FDA Updates | 0 |

The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.

Prisma Health Wins 2025 ECRI Award for Health Technology Excellence

Jun 26, 2025 | ECRI Institute | 0 |

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.

FDA Releases White Paper on Cybersecurity in Medical Manufacturing

Jun 24, 2025 | Cybersecurity | 0 |

New white paper highlights the need to secure operational technologies used in medical product production.

FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns

Jun 24, 2025 | FDA Updates | 0 |

Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.

ECRI Launches Free AI Resource Hub to Support Safe Implementation in Healthcare

Jun 23, 2025 | ECRI Institute | 0 |

ECRI has published a collection of resources that can help healthcare leaders safely integrate artificial intelligence (AI) solutions into care delivery.