Devices

FDA Approves Adjustable Implanted Cataract Lens

FDA has approved the RxSight Light Adjustable Lens and Light Delivery Device that can make small adjustments to an implanted lens after cataract surgery, allowing some patients to have better vision when not using glasses. An agency news release says the RxSight intraocular lens is made of a unique material that reacts to UV light, which is delivered by the Light Delivery Device 17-21 days after surgery. Patients, it says, receive three or four light treatments over a period of 1-2 weeks, each lasting about 40-150 seconds, depending on the amount of adjustment needed. Patients wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment, FDA says.

The agency says that a clinical study of 600 patients was conducted to evaluate the safety and effectiveness of the Rx Sight devices. Six months after the procedure, patients on average saw an improvement of about one additional line down the vision chart, for distance vision without glasses, compared to a conventional intraocular lens. Some six months after surgery, 75% of recipients also had a reduction in astigmatism.

The device should not be used in patients taking systemic medication that may increase sensitivity to UV light. It also is contraindicated in cases where patients have a history of ocular herpes simplex virus.

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