Devices

FDA Clears ‘At Home’ Male Fertility Test

FDA has cleared a Sandstone Diagnostics 510(k) for its Trak Male Fertility Testing System, an at-home diagnostic for couples to measure semen quality at home as they try to conceive. The device uses centrifugal force to isolate and quantify sperm cells using specially designed disposable cartridges, according to the company. It includes the “Trak Engine” and several disposable test kits for repeat testing.

“Trak is the first device cleared by the FDA that provides semi-quantitative results, classifying sperm counts as ‘Low,’ ‘Moderate’ or ‘Optimal’ based on World Health Organization guidelines and clinical studies that correlate higher sperm counts with faster time to pregnancy,” Sandstone says. “A fully-integrated digital health system, the Trak System pairs with the Trak mobile app (available free on Google Play, the Apple App Store and Amazon), to allow men to enter, track and compare their results to population statistics via the cloud-based community of users and clinical databases, and receive personalized feedback on lifestyle and wellness steps that may boost their sperm count.”

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