Devices

More Rigorous Studies Needed for Devices: Researchers

FDA should require more rigorous clinical studies for high-risk medical devices used in obstetrics and gynecology than currently required, according to researchers from Northwestern University. Their study, published in the journal Obstetrics and Gynecology, found that some high-risk devices were approved based on flawed data. “We found that there’s an opportunity to increase the burden of proof required for a device to be approved for public use,” said researcher Jessica Walter. The researchers identified 18 high-risk devices approved by the agency from 2000 to 2015, most of them for endometrial ablation (reducing menstrual flow), contraception and fetal monitoring. “Four of the devices – 22% – were approved even though they failed to demonstrate efficacy in clinical trials,” they say. “Six of the devices – 33% – were not required to undergo post-market studies to survey ongoing safety. Three devices were eventually withdrawn from the market after approval. Of those three, two were not reviewed by physician experts on the FDA’s obstetrics and gynecology advisory committee. The other was reviewed but not recommended for approval by the committee.” The researchers criticized Bayer’s controversial Essure permanent contraceptive device approved by the agency in 2002. “The device, meant to last a lifetime, was approved based on short-term evidence and insufficient post-market follow-up,” they say.“There are much higher standards for the approval of new drugs, whether oral, injectable or even topical. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?” Additionally, the researchers note that the House’s 21st Century Cures Act and a companion bill in the Senate contain provisions that would broaden the definition of “valid scientific evidence” manufacturers need in order to prove medical benefit. “Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective,” they caution.

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