Devices

FDA Clears EOGas 4 Ethylene Oxide Gas Sterilizer

FDA has cleared an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing duodenoscopes and colonoscopes. The device is labeled for sterilizing reusable medical devices that are sensitive to moisture, heat, corrosion or radiation, the company says. It was originally cleared in 2015 for surface sterilization use in a wide-range of instruments and for sterilization of endoscopes less than 1,100 mm in working length (bronchoscopes, bronchovideoscopes, cystoscopes, ureteroscopes, choledocoscopes, and gastroscopes). The new clearance is for endoscopes with greater than 1,100 mm working length (duodenoscopes and colonoscopes) with a maximum lumen length of 3,530 mm (11.6 feet) and minimum lumen diameter of 1.2 mm.

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

Read more

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