Drugs

SCANLY Home Optical Tomography Device Authorized

FDA has granted Notal Vision a de novo authorization for its patient self-operated SCANLY Home optical coherence tomography (OCT) device. The device was previously designated as a breakthrough device for patients suffering from wet, or neovascular, age-related macular degeneration. It captures spectral-domain OCT images in a 10 by 10-degree area centered on the point of fixation.

The authorization is based on data from two pivotal U.S. trials involving over 500 patients, which demonstrated that SCANLY is a “safe and efficacious way to visualize intra- and subretinal hypo-reflective spaces,” Notal Vision says. The trials found that 97% of all participants were able to successfully obtain OCT images at home, and self-imaging by patients took 48 seconds on average. “At the end of each session, images are automatically transmitted via a built-in wireless connection to the Notal Health Cloud for analysis,” it says. “Physicians can review data, set eye-specific notification criteria, including a volume threshold for total retinal hypo-reflective (TRO) spaces, and receive notifications through a HIPAA-compliant Web portal.”

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