Tag: FDA

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FDA Clears Avatar Medical Vision for 3D Imaging and Surgical Planning

The software supports CT and MR image visualization across standard displays, glasses-free 3D systems, and virtual reality environments.

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Why MDSAP and FDA QMSR Matter More Than Ever for HTM Teams

As MDSAP gains traction and FDA quality requirements align with ISO 13485, HTM teams have new ways to evaluate equipment reliability, serviceability, and long-term performance before purchase.

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FDA Launches Digital Health Pilot for Chronic Disease Technologies

The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.

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FDA Clears Avatar Medical Vision for 3D Imaging and Surgical Planning

The software supports CT and MR image visualization across standard displays, glasses-free 3D systems, and virtual reality environments.

FDA Warns of Injuries and Deaths Linked to Hyperbaric Oxygen Therapy

Aug 26, 2025

The agency reminds healthcare facilities to follow manufacturer instructions for use and maintenance after reports of fires, serious injuries, and deaths.

GE HealthCare Leads FDA AI Device Clearances for Fourth Consecutive Year

Aug 18, 2025

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

FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Aug 6, 2025

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

MDUFA VI Process Officially Begins With FDA Public Meeting

Aug 4, 2025

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.

Philips Receives FDA Clearance for Image-Guided Prostate Cancer Solution

Jul 28, 2025

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

Strengthening Industry-Government Relationships Amid Leadership Transitions

Jul 24, 2025

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

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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.