#us_food

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FDA approves Cochlear Nucleus Profile Plus Series implant

FDA has approved the new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor’s new built-in connectivity.

The US Food and Drug Administration (FDA) has approved the new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor’s new built-in connectivity.

[i-jacoblogan-blog]

FDA labels Ethicon surgical staplers recall as Class I

The US Food and Drug Administration (FDA) has labelled a recall of circular staplers by Johnson & Johnson (J&J) unit Ethicon as Class I, or high risk.

The US Food and Drug Administration (FDA) has labelled a recall of circular staplers by Johnson & Johnson (J&J) unit Ethicon as Class I, or high risk.

[i-jacoblogan-blog]

Medtronic’s Attain Stability left heart lead receives FDA nod

The US FDA has granted approval to Medtronic’s Attain Stability Quad MRI SureScan left heart lead designed to enable precise placement and stability.

The US Food and Drug Administration (FDA) has granted approval to Medtronic’s Attain Stability Quad MRI SureScan left heart lead. The device is the only active-fixation left heart lead, and is designed for precise lead placement and stability.

[i-jacoblogan-blog]

Boston Scientific gets FDA approval for LOTUS Edge system

Boston Scientific has received the US FDA approval for the use of LOTUS Edge Aortic Valve System to treat severe aortic stenosis.

Boston Scientific has received the US Food and Drug Administration (FDA) approval for the use of LOTUS Edge Aortic Valve System to treat severe aortic stenosis.

[i-jacoblogan-blog]

The US Food and Drug Administration (FDA) has granted clearance to surgical solutions developer Innoblative Designs’ SIRA RFA Electrosurgical Device.

The US Food and Drug Administration (FDA) has granted clearance to Innoblative Designs’ electrosurgical device SIRA RFA.

[i-jacoblogan-blog]

FDA grants expanded indication to Abbott’s MitraClip device

The FDA has expanded the indication of Abbott’s MitraClip device to include certain heart failure patients with clinically significant secondary MR.

The US Food and Drug Administration (FDA) has expanded the indication of Abbott’s MitraClip device to include the treatment of heart failure patients with clinically significant secondary or functional mitral regurgitation (MR).