Devices

Lungpacer Gains Expedited Access Pathway

FDA has granted Lungpacer Medical an Expedited Access Pathway (EAP) designation for the Lungpacer Diaphragm Pacing System for treating patients who have been unable to wean from mechanical ventilation. Traditional mechanical ventilation can be harmful to a patient because it interrupts the normal activation of the diaphragm muscle, which then atrophies rapidly (ventilator induced diaphragm dysfunction), according to the company. It says its proprietary Lungpacer system is designed to activate the diaphragm using a temporary, transvascular nerve stimulation approach that is expected to restore diaphragm strength and endurance in patients who have failed to wean after their diaphragm muscle atrophied.

With an EAP designation, the agency works with device manufacturers to try to reduce the time and cost from the start of product development to marketing approval, without changing approval standards. Components of the program include priority review, more interactive review, senior management involvement, and assignment of a case manager. Additionally, it can lead to potentially less burdensome premarket clinical trials, while shifting a portion of data collection to the post-market phase.

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