Devices

Women Underrepresented in Device Trials: Research

Writing in a JAMA Internal Medicine research letter, Israeli researchers say that despite a 2014 FDA guidance, women have been underrepresented in medical device clinical trials. The researchers say that CDRH recently issued a strategic plan for improving women’s representation in medical device trials.

“We found that device trials randomized a median of 33% of women,” the letter says. “The participation-to-prevalence ratio for most common devices was less than 0.8, implying underrepresentation of women, as has been demonstrated in older device trials showing lower representation than drug or lifestyle interventions.”

The article identifies obstacles to women’s inclusion as concerns about fetal consequences, underdiagnosis or under-referral of women, perceived recruitment challenges, and inclusion and exclusion criteria favoring men.

It says that solutions proposed include equal enrollment of women to their share in the population with disease or planning a sample size that could detect gender differences.

“Improved awareness and initiatives are essential to ensure adequate enrollment, considering potential gender-specific differences in medical device performance,” the researchers conclude.

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