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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
Medical software that allows caregivers to noninvasively evaluate blood flow in patients with coronary artery disease gained marketing clearance from the FDA late last month. 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