Devices

Tute Genomics DNA Project Closed after FDA Letter

A Kickstarter funding campaign launched by Tute Genomics to give consumers access to their personal genetic information has been postponed after receiving an FDA letter concerning its approach to marketing genome sequencing and analysis directly to consumers. In a note on Kickstarter, Tute Genomics CEO Reid Robison says that “after much deliberation and active discussion with FDA, it is with great sadness that we are postponing this campaign. I still strongly believe that everyone should have a right to and own their DNA, but they should also respect FDA and their credo to protect the consumer. I think both aims can be achieved and we’re proactively engaging with FDA and working on the right path forward to make this happen.”

The note says that the quest to give consumers empowering self-knowledge from their genetic code has been fraught with regulatory obstacles, citing the FDA 2013 order that 23andMe stop selling its personal genome service. Since then, Robison says, genomics companies have had to proceed cautiously with regard to the consumer, “but we felt that this issue was too important to sit idly by.”

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