Tag: FDA

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The Factors Behind OEM vs Aftermarket Parts Decisions

For HTM teams, parts sourcing decisions depend on far more than price or availability.

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Medcrypt Launches Platform to Support Cybersecurity Compliance for Device Manufacturers

The software is intended to help manufacturers demonstrate cybersecurity maturity as expectations from regulators and hospital purchasers continue to rise.

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GE HealthCare Leads FDA AI Device Clearances for Fourth Consecutive Year

The company has now accumulated over 100 authorizations for artificial intelligence in its medical technology portfolio.

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The Factors Behind OEM vs Aftermarket Parts Decisions

For HTM teams, parts sourcing decisions depend on far more than price or availability.

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.

FDA Finalizes Medical Device Cybersecurity Premarket Guidance

Jun 27, 2025

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

FDA Releases White Paper on Cybersecurity in Medical Manufacturing

Jun 24, 2025

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

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

FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls

Jun 4, 2025

Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.

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FDA Authorizes AI Platform for Breast Cancer Prediction

The FDA grants De Novo authorization for a new device for future five-year breast cancer risk prediction, based on an image alone.