Tag: FDA

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Texas Directs Healthcare Facilities to Align With FDA Medical Device Cybersecurity Guidance

State officials are urging hospitals to review device cybersecurity risks and align policies with FDA guidance.

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FDA to Accept De-identified Data for Certain Medical Devices Submissions

New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.

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Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process

New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.

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Texas Directs Healthcare Facilities to Align With FDA Medical Device Cybersecurity Guidance

State officials are urging hospitals to review device cybersecurity risks and align policies with FDA guidance.

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

Jul 23, 2025

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.

BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts

Jul 21, 2025

The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.

BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues

Jul 15, 2025

Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.

FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound

Jul 1, 2025

Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.