Devices

Optometric Group Urges FDA Action Against Online Eye Test

The American Optometric Association (AOA) has filed a complaint with FDA urging it to take legal action against an online vision test being marketed by Opternative, Inc. without the type of testing and pre-market approvals frequently required of new medical device technology. The online test produces a prescription for eyeglasses or contact lenses without any patient examination by an eye care professional and without taking into account the patient's overall medical condition, AOA says.

The group’s complaint challenges claims made by Opternative about its product’s capabilities, and calls for enforcement action to remove it from the market until it can be shown to meet all appropriate federal requirements for medical devices. AOA also says the test has a significant potential for yielding inaccurate prescriptions, and is not adequate to safely yield a contact lens prescription.

“No product or company can or should be allowed to operate outside appropriate Ffderal oversight when vision and overall health are at stake,” the group says. It notes that Michigan recently issued a cease and desist order against Opternative for violating the state’s consumer protection law.

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