Devices

Lasik Injury Advocate Steps Up Pressure on ‘Illegal Ads’

Lasik injury advocate and Vision Advocacy president Paula Cofer has stepped up pressure on FDA commissioner Robert Califf, sending him a second “illegal advertisement” for the EVO Visian implantable collamer lens (ICL) and asking that the agency take action against the promotions that are “masquerading as a news article.”

The latest ad appeared in the Chicago Daily Herald on behalf of Kevin J. Kovach of Kovach Eye Institute. The ad, like the previous “illegal” ad she reported (see story) by Dr. Gregory Parkhurst, “trivializes this risky, unnecessary device which is intended for implantation into young, healthy eyes, and it does not mention any of the device's risks or limitations,” Cofer said in an email to Califf.

“This is not only the second illegal ad that I've seen recently for EVO Visian ICL,” she continued. “I’m actually trying to ignore them because I have lost faith in the FDA to take any action against illegal refractive surgery device advertisers, but this is a serious threat to public health. Someone has to speak up. The FDA cannot allow this to continue. Please stop illegal advertising of EVO Visian ICL without further delay!”

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