Tag: FDA

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Class I Recall Expanded for Alaris Pump Infusion Sets

The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.

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Philips Receives FDA Clearance for Image-Guided Prostate Cancer Solution

The newly cleared platform combines MR and ultrasound imaging to support real-time guidance for focal therapy and improve clinical accuracy.

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FDA Releases White Paper on Cybersecurity in Medical Manufacturing

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

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Class I Recall Expanded for Alaris Pump Infusion Sets

The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.

Tariffs Create Ripple Effects Across Medical Device Regulatory Pathways

May 6, 2025

Changes in suppliers and manufacturing locations to avoid tariffs can require new regulatory filings, increasing time and cost burdens across global markets.

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.

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

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