Devices

FDA OKs Synapse Bio PMA for Breathing System

FDA has approved a Synapse Biomedical PMA for the NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries who rely on mechanical ventilation. The company says the device is designed as an option for spinal cord injury (SCI) patients who prefer a “more natural method of breathing. Rather than using positive pressure (forced air), NeuRx DPS provides negative pressure ventilation which mimics the body’s natural breath cycle.”

The battery-powered device works by delivering electrical stimulation via four percutaneous intramuscular electrodes implanted into the diaphragm using laparoscopy, according to the company. “It is intended for use in patients with stable SCI with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow patients 18 years and older to breathe without the assistance of a mechanical ventilator for at least four continuous hours a day. Many patients have gone on to use the device up to 24 hours per day, it says.

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

Read more

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