Devices

FDA Approves Concordia PMA for New PDT Laser

FDA has approved a Concordia International PMA for its new Photofrin 630 Photodynamic therapy (PDT) laser. The cancer treatment combines a photosensitizing drug called Photofrin (porfimer sodium) with a specific type of light-energy laser to attack cancer cells, the company says. The device, which is designed to treat esophageal cancer, Barrett’s Esophagus and non-small cell lung cancer, has been re-engineered with “technological advancements” in laser design, including new controls and peripheral systems while maintaining the same specifications with minimal changes to treatment procedures, it says. Additionally, Concordia is evaluating Photofrin as a rare disease product candidate through a Phase 3 clinical trial for treating cholangiocarcinoma (bile duct cancer), which affects less than 3,000 patients annually in the U.S.

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