Devices

Quanterix Gets Breakthrough Status for Alzheimer’s Test

FDA has granted Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 (p-Tau 217) blood test as an aid in diagnostically evaluating Alzheimer’s Disease (AD). The company says p-Tau 217 is a “top-performing biomarker” for AD pathology, noting that an Alzheimer’s Association working group identified p-Tau 217 as the only plasma biomarker appropriate for accurately diagnosing amyloid pathology. “Given that traditional testing methods of positron emission tomography or lumbar puncture for cerebrospinal fluid biomarkers are invasive and commonly inaccessible, high-performing blood-based biomarker tests may be an appropriate alternative for patient care,” it says.

The Simoa p-Tau 217 test is described as a semi-quantitative in vitro diagnostic immunoassay intended for measuring p-Tau 217 concentration in plasma using the Quanterix HD-X immunoassay system. “Proposed indications include use of the test results in patients presenting with cognitive impairment who are being evaluated for AD risk to aid in diagnostic evaluation,” the company says, adding that such results are not intended as a stand-alone diagnostic test and they should be interpreted in conjunction with other diagnostic tools to establish a final clinical diagnosis.

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