Devices

Petition Asks FDA to Investigate Mayo Robotic Mastectomy

A petition submitted by Harmed Americans for Reform in Medical Device Safety (HARM) calls on FDA to investigate Mayo Clinic's promotion and use of robotic nipple-sparing mastectomy using a da Vinci surgical system. The petition says Mayo is using the robotic system outside the ongoing IDE. It also asks the agency to investigate Intuitive Surgical’s role in the promotion, reevaluate clearance of the da Vinci system, require postmarketing surveillance and labeling changes, and communicate with the Centers for Medicare and Medicaid Services to clarify the IDE status of robotic mastectomy and reimbursement implications.

HARM is led by cardiac surgeon Hooman Noorchashm, known to FDA for his opposition to power morcellation and for raising issues about surgical mesh.

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

Read more

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