Devices

FDA Clears Prostate Tissue Ablator

FDA has cleared an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation. The clearance was based on data from the pivotal PRESERVE clinical study that evaluated the safety and effectiveness of the system in patients with intermediate-risk prostate cancer.

The study met its primary effectiveness endpoint, according to the company, adding that at 12 months post-procedure, 84% of men were “free from in-field, clinically significant disease. In addition, the study demonstrated strong quality of life outcomes with short-term urinary continence being preserved (96.6% at baseline, 95.4% at 12 months) and the ability to maintain erections sufficient for intercourse only decreasing 9% compared to baseline (80.7% to 71.7%).”

The device is described as the first and only non-thermal, radiation-free, ablation technology designed to treat prostate tissue using irreversible electroporation, a nonthermal ablative technology that uses high-voltage, low-energy DC current pulses to induce cell death.

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