Devices

Inspire Recalls Implantable Pulse Generator

Inspire Medical Systems is recalling (Class 1) its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect, which can cause system malfunctions and an electrical leakage in the sensing circuit. “As a result, patients may need revision surgery to replace the IPG and restore therapy,” a recall notice says. Using an affected product may cause serious adverse health consequences, including stimulation below normal therapeutic levels or early battery depletion (loss of therapy), inappropriate or inconsistent stimulation effect, painful stimulation or perceived shocking sensation and death, it says. To date, there have been no reported injuries.

The IPG is part of the Inspire Upper Airway Stimulation system. It stores therapy settings input by a physician and delivers mild electrical stimulation to the hypoglossal nerve to control tongue muscles to maintain airway patency during sleep, according to the company. “The IPG works together with external programmers that allow the physician to set and adjust the therapy parameters and the patient to control the therapy's activation and intensity,” the notice 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