Devices

FDA OKs Expansion of Obesity Study

FDA has approved the expansion of a USGI Medical pilot study of it endoscopic procedure known as POSE 2.0. The study is designed to evaluate weight loss for adults suffering from obesity with a body mass index (BMI) of 35 to 40 kg and an obesity-related comorbidity, such as diabetes or hypertension. The procedure uses USGI Medical’s Incisionless Operating Platform to strategically place durable Snowshoe Suture Anchors in gastric tissue to both shorten and narrow the stomach, according to the company. It provides volumetric gastric restriction, like that achieved by a surgical sleeve gastrectomy, without amputating part of the stomach, it says. “Patients treated with the POSE procedure typically return to work in just one to two days without any scars or signs of surgery.”

During the first stage of the U.S. pilot study, patients evaluated at the midpoint follow-up of six months achieved on average 12.5% total body weight loss (TBWL). “All patients responded to treatment with a clinically meaningful TBWL greater than 5%, and 60% of patients achieved TBWL of greater than 13%,” USGI 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

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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