Devices

FDA Clears Peritoneal Dialysis Disinfecting Device

FDA has cleared a PuraCath Medical 510(k) for the FireFly Peritoneal Dialysis Connector Disinfecting System, intended for use by peritoneal dialysis (PD) patients as a method of controlling air and touch contamination while performing solution exchanges. The clearance was supported by in vitro testing that the company says demonstrated the device’s effectiveness in “achieving a 4-log reduction for several microorganisms which are known to cause peritonitis in PD patients.” The device reduces microbial growth through the use of a UV light-based PD disinfection system, it says.

Peritoneal dialysis is a home-based dialysis therapy that “offers patients a more flexible and physiologically smoother dialysis option,” PuraCath says. “Unlike hemodialysis, peritoneal dialysis uses a patient’s peritoneal membrane to remove toxins and excess fluid from the patient. Peritoneal dialysis therapy permits patients to have a more regular diet and more flexible treatment times, improving their quality of life.”

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