Tag: FDA

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FDA CDRH Leaders to Speak at Town Hall at the 2025 MedTech Conference

The session will provide an update on the center’s strategic direction and priorities and include a question-and-answer period for attendees.

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Strengthening Industry-Government Relationships Amid Leadership Transitions

Advocacy built on long-term relationships can help HTM professionals stay influential as agency leaders and lawmakers change.

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FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns

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

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FDA CDRH Leaders to Speak at Town Hall at the 2025 MedTech Conference

The session will provide an update on the center’s strategic direction and priorities and include a question-and-answer period for attendees.

Opinion: Right to Repair Must Stop Where Patient Safety Starts

May 5, 2025

A former FDA official argues that medical device repair needs stricter oversight to protect patient safety amid growing right to repair efforts.

FDA Warns ICU Medical Over Infusion Pump Modifications

Apr 29, 2025

The FDA has issued a warning letter to ICU Medical, citing regulatory violations related to unapproved modifications to two of its infusion pumps.

AAMI Announces Advisory Council and Location for 2026 neXus Conference

Apr 23, 2025

AAMI has named the advisory council and selected a venue for its 2026 medical device standards-focused conference.

AdvaMed Unveils AI Policy Roadmap to Guide Medtech Regulation and Innovation

Apr 22, 2025

New framework calls for clear regulatory pathways, data access reform, and reimbursement strategies to advance AI-enabled medical devices.

FDA Clears AI Software Validated to Guide Novices in Cardiac Imaging

Apr 15, 2025

In a blind review, scans performed by novices using the software met diagnostic standards and matched expert-level quality.

What to Ask Before Signing a Third-Party Medical Equipment Service Contract

Mar 28, 2025

Asking the right questions helps ensure quality service, control costs, support compliance, and avoid surprise charges or service gaps.

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FDA Recognizes Updated AAMI Sterilization Guidance

The FDA has added one new and three revised AAMI sterilization documents, including guidance on ethylene oxide, to its list of Recognized Consensus Standards.