Devices

FDA Rejects Pulse Bio Expanded Use on CellFX

FDA has rejected a Pulse Biosciences 510(k) for an expanded indication to treat sebaceous hyperplasia with its cleared CellFX System powered by Nano-Pulse Stimulation technology. In a 2/5 Additional Information letter, the agency said the company had not provided sufficient clinical evidence at this time to support the expanded indication for use, and that it had not met the primary endpoints of the sebaceous hyperplasia FDA-approved IDE study. Pulse Bio says it will request a meeting with FDA to discuss the letter.

In the U.S., the device is cleared for dermatologic procedures requiring ablation and resurfacing of the skin and intended use of treating benign lesions, according to the company. In Europe, it is approved for treating sebaceous hyperplasia, seborrheic keratosis and non-genital warts.

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