Devices

FDA Clears Butterfly Network ‘Ultrasound-on-a-Chip’

FDA has cleared a Butterfly Network 510(k) for what the sponsor describes as the world’s first “ultrasound-on-a-chip” based imaging system, the Butterfly iQ for the iPhone. The clearance covers 13 clinical applications, the “broadest ever for a single ultrasound transducer,” the company says. “By combining almost 10 thousand sensors, 40 times more than systems costing 100 times as much, Butterfly ushers in a new era of accessible, high-performance medical imaging.”

Butterfly's ultrasound-on-a-chip technology combines the capabilities of the typical three probes into a single ultra wide-band, 2D matrix array that comprises thousands of microelectromechanical systems, the company says. “These sensors are directly overlaid on an integrated circuit encompassing the electronics of a high performance ultrasound system.”

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