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Proof that a diagnostic test could be safely performed by untrained workers convinced the FDA to grant a first-ever regulatory waiver for a syphilis rapid screening assay. Read More
Manufacturers of passive implants, such as surgical screws, must begin subjecting products to magnetic resonance testing to see if they become dangerous when exposed to MR systems and radiofrequency heating, the FDA says. Read More
EU leaders are deadlocked over a proposed premarket mechanism for the highest-risk devices, and the stalemate threatens to delay adoption of a major overhaul in device and diagnostic regulations until late next year or even 2016. Read More
The agency cleared the company’s ReSolve biliary locking drainage catheter, the ONE Snare endovascular microsnare system and the AEROmini tracheobronchial stent system. Read More
The FDA is ratcheting up safety controls on infusion pumps, mandating that developers of new pumps follow stricter requirements for design validation and verification and provide more detailed applications to address safety hazards associated with pumps used in the home. Read More