Devices

Emergency Use for Device to Wean Ventilator Use

FDA has granted an emergency use authorization for Synapse Biomedical and its TransAeris Diaphragmatic Pacing Stimulator System that is intended to help wean patients off ventilators, including COVID-19 patients. Diaphragm pacing can free up ventilators as patients are moved off ventilators and placed on the pacing system, the company says.

The device works with temporary small electrodes implanted to stimulate the diaphragm. Diaphragmatic Pacing was initially developed for patients with spinal cord injuries, but it has proven effective in helping patients get off ventilators in intensive care units. “In spinal cord injured patients, we have decreased time on a ventilator from 30 to 10 days,” the company says. “Patients with pneumonias have a significantly decreased amount of ventilator days when [diaphragmatic pacing] is used.”

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