Devices

FDA Safety Alert on OxySure Portable Oxygen Device

FDA says a 6/2015 recall by OxySure Therapeutics involving its OxySure replacement cartridges for the OxySure Portable Emergency Oxygen System Model 615 was ineffective. A new agency alert recommends that consumers, businesses, schools, and health care providers stop using the devices because of several device malfunctions, including ineffective oxygen delivery and chemical reactions in the canisters that could cause them to explode.

FDA says it inspected the firm in 2014 and cited the company’s internal testing which revealed the device’s oxygen flow rate to be too low, not meeting the FDA-cleared minimum specification of six liters per minute for a minimum of 15 minutes. A subsequent Warning Letter also cited the firm for deficiencies in addressing oxygen flow rate problems. In 2015, the company issued a “Field Correction Action Notification” informing customers of the problem and instructing them to review their inventory and dispose of the affected product.

FDA says it conducted a follow-up inspection 9/2015 and determined that the device’s oxygen flow rate again failed to meet the FDA-cleared minimum specifications. Because the recall efforts were ineffective in resolving the issues, the agency now recommends users discontinue using the device and immediately transition to an alternative FDA-cleared emergency oxygen device (searchable under product code “CAW”).

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