Devices

Medtronic ‘Breakthrough’ for Lung Lesion Ablator

FDA has granted Medtronic a breakthrough device designation for the Emprint ablation catheter kit, which is intended to be used in conjunction with the Emprint microwave generator and Medtronic lung navigation platform for localized treatment of malignant lesions in the lung. “Using an endoluminal approach, the Emprint ablation catheter kit will be studied with the Medtronic lung navigation system to allow for accurate delivery of microwave energy to the targeted lung lesion(s),” the company says. Clinical guidelines recommend local therapies such as thermal ablation in combination with systemic therapies when suitable, it adds.

Medtronic says its lung navigation platform enables precise and accurate placement of the ablation catheter within the target lesion. The device has been on the market for 15 years and used in 200,000 lung procedures.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome