Devices

Marketing Permitted for Innovative Diabetic Retinopathy Screen

FDA has allowed the de novo marketing of IDx LLC.’s IDx-DR, a software program that uses an artificial intelligence (AI) algorithm to analyze images of the eye taken with a retinal camera to detect greater than a mild level of diabetic retinopathy. Diabetic retinopathy occurs when high blood sugar levels cause damage to the retina’s blood vessels, which can in turn cause vision loss.

The AI evaluation is performed after digital images of a patient’s retinas are uploaded to a cloud server on which IDx-DR software is installed. The screening will provide doctors with results that either detect more than mild diabetic retinopathy (referral recommended to see an eye care provider) or a negative response and a recommendation to rescreen in 12 months.

The de novo authorization was based data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites, according to an agency notice. “In the study, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4% of the time and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5% of the time,” it says.

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