Devices

Alcresta’s ReliZorb Cleared for Younger Children

FDA has cleared an Alcresta Therapeutics 510(k) for an expanded use of ReliZorb in children ages two to five years. ReliZorb is a digestive enzyme cartridge designed to mimic the function of pancreatic lipase. It was first cleared in 2015 for use in adults, and subsequently cleared in 2017 for use in children as young as five. The company says the device is the only enzyme product cleared by FDA for use with enteral feeding. “This additional ReliZorb clearance represents access for approximately 25% of the cystic fibrosis enterally fed market and for enterally fed pediatric patients ages two to five years suffering from conditions that contribute to fat malabsorption,” Alcresta says.

The expanded clearance is based on a retrospective evaluation of real-world data in patients who received enteral formula administered through ReliZorb as part of an enteral feeding regimen, the company says, adding that no additional safety concerns were identified in this new patient population.

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