Devices

Implantica Submits Final FDA Response for RefluxStop PMA

Implantica says it has submitted the final response to FDA on its PMA for RefluxStop that addresses the agency’s remaining questions tied to Module 3 of the submission and includes additional testing that followed a previously disclosed 100-Day Meeting.

Implantica said the FDA has now completed reviews of all three PMA modules and conducted six preapproval inspections covering manufacturing facilities, quality systems, and Bioresearch Monitoring inspections related to the clinical trial program. According to the company, the inspections concluded successfully.

RefluxStop is designed as a surgical treatment for gastroesophageal reflux disease, or GERD, intended to restore the body’s natural anatomy without compressing the esophagus. The device differs from traditional anti-reflux surgical procedures that wrap around the esophagus and can lead to complications such as difficulty swallowing, gas bloating, or inability to belch or vomit.

The PMA is supported by long-term clinical data, including five-year follow-up data from the company’s pivotal clinical study requested by the FDA. Implantica says the findings have been published in peer-reviewed scientific journals and demonstrated favorable long-term safety and efficacy outcomes.

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