Category: FDA Updates

FDA Updates

FDA Cites Royal Philips for Manufacturing Violations in China

The FDA sent a warning letter to Royal Philips over its manufacturing practices at a plant in China that produced CT equipment.

FDA Updates

Teleflex Recalls Certain Arrow Catheterization Kits

Teleflex is recalling the Arrow QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits after reports of issues.

FDA Updates

FDA OKs Zimmer Biomet’s ROSA Shoulder System

Zimmer Biomet Holdings has nabbed U.S. FDA clearance for the ROSA Shoulder System, a robotic assistant for shoulder replacement surgeries, providing surgeons with flexibility, improved placement accuracy, and data-driven decision-making capabilities.

Clearances

FDA Approves DermaSensor Skin Cancer Evaluation System

DermaSensor received FDA clearance for its AI-powered, real-time, non-invasive skin cancer evaluation system.

Recalls

GAO to Investigate FDA’s Medical Device Oversight

The Government Accountability Office (GAO) is launching an investigation into the U.S. FDA's potentially ineffective policies for recalling medical devices, prompted by concerns raised by Senators Durbin and Blumenthal regarding the slow response to recalls of Philips Respironics CPAPs, BiPAPs, and mechanical ventilators.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Establishes Digital Health Advisory Committee

The FDA is establishing a Digital Health Advisory Committee in 2024, comprising experts from various fields, to advise on the safe and effective regulation of digital health technologies like AI, virtual reality, and wearables, aiming to promote innovation while safeguarding public health.