FDA Updates On Hyperinflation, Pancreatitis Risks Of Implantable Liquid-Filled Weight-Loss Balloons
A letter from the US agency clarifies the risks of over-inflation, acute pancreatitis and death in patients who have been treated with liquid-filled intragastric balloons.
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US FDA has approved updated labeling for Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System in the wake of five more patient deaths.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.
A year after Congress officially gave the FDA the power to ban devices for a specific use, the school that inspired the new law is taking the agency back to court on allegations it has failed to respond to document requests.