Devices

New Monteris Medical NeuroBlate Probe Coming: FDA

FDA says it has cleared a new Monteris Medical NeuroBlate probe containing a non-metallic fiber optic temperature sensor to address unintended probe heating in the magnetic resonance environment. The new probe replaces the metallic thermocouple temperature sensor of the original probe that was the subject of an agency 3/22 letter to healthcare providers about a Class 1 recall due to several instances of unintended heating and damage to the probe that may have resulted in unintended damage to surrounding brain tissue.

“The safety risks associated with the use of the probe with the metallic thermocouple temperature sensor still remain,” an agency online update says. “Until the new probe with the fiber optic temperature sensor is available, healthcare providers should consider the benefits and risks of the probe with the metallic thermocouple, as well as the availability of alternative treatment modalities.”

FDA also posted an update on the risk of tissue overheating due to inaccurate magnetic resonance thermometry. That update contains additional recommendations to help protect patient safety and mitigate the risks of tissue overheating because of potentially inaccurate magnetic resonance thermometry readings during use of magnetic resonance-guided laser interstitial thermal therapy devices.

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

Read more

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