Devices

Breakthrough Devices Could Aid Disadvantaged: Attorneys

A 9/15 FDA update to its guidance on breakthrough medical devices says the agency may consider a device’s ability to improve health and healthcare disparities when deciding whether to award a breakthrough medical device designation. Writing in an online post, attorneys Thomas Greeson and Sung Park (Reed Smith) say the agency may use the information to determine whether a candidate device provides more effective treatment or diagnosis when compared to the current standard of care.

“We recommend that medical device manufacturers that are currently developing medical devices and reviewing whether their devices are eligible for the breakthrough device designation consider whether the medical device has the potential to address and improve health and healthcare disparities and inequity,” they write. “The potential to address such disparity or inequity may impact FDA’s analysis and determination. If the device addresses such disparities and/or inequality, the manufacturer should highlight this aspect to FDA, and explain how this may improve outcomes for patients and users.”

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