Devices

GE Wireless Maternal/Fetal Monitor Cleared

FDA has cleared a GE HealthCare 510(k) for its Novii+ Wireless Patch, an antepartum and intrapartum maternal and fetal monitor that measures and displays in real time fetal heart rate, maternal heart rate and uterine activity. “Novii+ allows moms to move around and stay active during labor while providing reliable monitoring for their care teams,” the company says. “Novii+ is an expanded indication from the Novii Maternal and Fetal Monitoring Solution that utilizes an updated algorithm (cross check artifact reduction) to improve reliability and accuracy.”

GE says the expanded indication is based on data submitted to demonstrate the device’s equivalence to doppler fetal heart rate, tocodynamometer uterine activity and pulse oximetry maternal heart rate devices. “Novii+ provides a personalized view of the mother and fetus’ statuses, and alerts care teams for changes to heart rate and contraction pattern during labor, so they can proactively intervene,” it adds.

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