Devices

FDA De Novo for Angle Liquid Biopsy Device

FDA has granted de novo authorization to Angle plc for its Parsortix system for use in harvesting cancer cells from metastatic breast cancer patient blood for subsequent analysis. “This FDA regulatory clearance is the culmination of a sustained effort by the company for over six years including extensive dialog and formal pre-submissions with FDA, and the submission of over 400 technical reports and documents and processing of over 16,000 samples to demonstrate system performance,” Angle says.

The device’s capability to harvest cancer cells for analysis from a patient blood sample has the potential to transform cancer treatment decisions because “it opens up the opportunity for repeat non-invasive biopsies to assess cancer status” (liquid biopsies), the company says. It believes intact living cancer cells are the “best sample” for analysis, “adding vital additional information to the current industry approach of analyzing fragments of dead cancer cells (known as ctDNA).”

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