Devices

FDA Approves Abbott PMA for 1st Depth-of-Focus IOL

FDA has approved an Abbott Medical Optics PMA for what the agency describes as the “first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.” Traditional monofocal IOLs have been limited to improving distance vision, an agency release says. “The Tecnis Symfony IOL improves visual acuity at close, intermediate and far ranges and, therefore, may reduce the need for patients to wear contact lenses or glasses after cataract surgery,” it says.

Approval is based on clinical trial data comparing 148 cataract patients implanted with Abbott’s device to 151 cataract patients implanted with a monofocal IOL. “Of the patients implanted with the Tecnis Symfony IOL, 77% had good vision (20/25), without glasses at intermediate distances, compared to 34% of those with the monofocal IOL,” FDA says. “For near distances, patients with the Tecnis Symfony IOL were able to read two additional, progressively smaller lines on a standard eye chart than those with the monofocal IOL. Both sets of patients had comparable results for good distance vision.”

The agency cautions that patients implanted with the Tecnis Symfony IOL may experience worsening or blurred vision, bleeding or infection. It may also cause “reduced contrast sensitivity” which worsens under poor visibility conditions (fog, dim light).

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