Devices

Circa Scientific Esophageal Temperature Probe Cleared

FDA has cleared a Circa Scientific 510(k) for its S-CATH M Esophageal Temperature Probe which can be visualized on 3D cardiac mapping systems during cardiac ablation procedures. The multi-sensor probe is intended to provide high-density, edge-to-edge coverage of the esophagus, and being visualized on cardiac mapping systems could help physicians reduce their dependence on fluoroscopy, according to the company. “Esophageal temperature probes can be used to alert physicians to critical esophageal temperature changes that may occur during cardiac ablation procedures performed in the operating room or electrophysiology lab,” it says. Fluoroscopy use requires physicians and lab personnel to wear protective lead aprons to protect themselves from radiation exposure.

The S-CATH M has four electrodes that are placed down the centerline of the probe, enabling it to be placed, positioned, and visualized on 3D mapping, the company explains. It also features a “proprietary micro-electrode design that limits the amount of exposed metal to only what is absolutely necessary to be detected on 3D cardiac mapping systems, minimizing the opportunity for radiofrequency (RF) interaction,” it says.

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