Tag Archives: Cleared

Brexanolone (Zulresso) for Postpartum Depression Cleared by the DEA, Now Available

Brexanolone, to be marketed by Sage Therapeutics as Zulresso, was initially approved in March 2019, as a treatment for postpartum depression.  At that time, we were told that Zulresso would be available in June 2019. Here are a few updates. The Drug Enforcement Administration (DEA) has recommended that brexanolone be placed in schedule IV of… Read More »

Nexus Ultrasonic Surgical Platform from Misonix FDA Cleared

June 5th, 2019 Medgadget Editors Cardiac Surgery, Oncology, Orthopedic Surgery, Plastic Surgery, Surgery Mixonix, a Farmingdale, New York company that specializes in ultrasonic devices for surgical applications such as osteotomies and debridements, won FDA clearance for the new Nexus surgical platform. The Nexus combines the capabilities of Mixonix’s three existing products, namely BoneScalpel, SonicOne and… Read More »

Miris Human Milk Analyzer Cleared by FDA to Measure Nutritional Content for Donor Milk

January 7th, 2019 Editors Medicine, News, Pediatrics Donor human milk is a standard of care in many maternity wards caring for preterm infants. While very effective, the nutritional content of donor milk is often subpar and requires targeted fortification. Miris, based in Uppsala, Sweden, won FDA clearance for its Human Milk Analyzer, a novel device used… Read More »