Devices

4 Senators Urge Study on Pulse Oximeters

Four Democrat U.S. senators are urging FDA to initiate a post market study of pulse oximeters and seeking information about the agency’s clearance process for pulse oximeters to ensure they are effective across racially diverse patients and consumers. In a letter to FDA commissioner Robert Califf, Elizabeth Warren (D-MA), Cory Booker (D-NJ), Ed Markey (D-MA), Ron Wyden (D-OR), and Tammy Duckworth (D-IL) said the request follows up on a previous letter sent by the four lawmakers.

“There are decades of research showing inaccurate results when pulse oximeters are used to monitor people of color, particularly patients with darker skin,” they wrote. “Therefore, we are seeking information from the FDA on your clearance of pulse oximeters and urge the FDA to initiate a post market study for these devices to understand what improvements to the technology will make the devices effective on the full range of human skin pigmentation.”

Last year, FDA issued a safety alert on the limitations of pulse oximeters. “While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings,” the agency said. The alert also identified several factors that can affect the accuracy of a pulse oximeter reading, including poor circulation, skin pigmentation, skin thickness, skin temperature, tobacco use and fingernail polish. In June, FDA said it was convening an advisory committee meeting to review data on the devices.

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