Devices

Reducing the Potential for Pulse Oximeter Bias

Medtronic says it supports FDA efforts to further enhance industry standards for pulse oximeters and to reduce potential health disparities related to using the devices by considering skin pigmentation, race, and ethnicity. Commenting on an agency discussion paper on the topic, Medtronic says that while there is still work to do to finalize guidelines and standards for using pulse oximeters, “we have made significant progress over the past 18 months, which is reflected in FDA’s discussion paper. We believe that by being united in purpose (across FDA, industry, patient groups, and other stakeholders), our collective efforts will culminate in transformative change in this area, ensuring equitable care for all patients regardless of skin color.”

In its response, AdvaMed says FDA should set requirements that are supported by scientific evidence. “There is not yet enough data to support the agency’s recommendations around non-disparate bias requirements,” it says. It also notes such a requirement is not in the draft International Standards Organization standard with which AdvaMed says FDA should align its standard and any future guidance.

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