Devices

ClearPoint Brain Modeling Software Cleared

FDA has cleared a ClearPoint Neuro 510(k) for use of its ClearPoint 2.2 software with the integrated Maestro Brain Modeling. “The ClearPoint system can now offer fast, peri-procedural segmentation of the cortical structures of the brain to identify both targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation,” the company says.

Maestro was cleared 8/2022 for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. “The unique methodology of the Maestro Brain Model combines deformable surfaces with active shape models and machine learning,” the company says. “More importantly, it provides point-based correspondence longitudinally and across patients. Cross-validation on more than 1,000 scans demonstrate highly reproducible results with sub-millimeter accuracy and normative values from 560 healthy subjects provide reference ranges for patient-specific assessments.”

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