Devices

FDA Clears Abbott’s Concussion Blood Test

FDA has cleared Abbott’s i-STAT TBI (traumatic brain injury) cartridge to be used with whole blood to assess patients with suspected concussion at the patient’s bedside within 15 minutes. Previously, tests to help assess TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing, the company says.

“This new clearance will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments including urgent care clinics with a certificate to perform moderate complexity tests,” Abbott says. “This is an important step toward a future where testing could be done outside traditional healthcare settings, such as on the sidelines of sporting events.”

The portable instrument blood test is intended to help clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury (concussion), Abbott says. “Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care,” it adds.

The i-STAT TBI cartridge requires a small venous blood sample, which is applied to the test cartridge, Abbott says, adding that the test measures two biomarkers from the brain that may be released into the bloodstream, indicating a possible brain injury. “Testing for these two biomarkers – ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) – in the aftermath of an injury can provide clinicians with essential information about a patient's condition and can help healthcare providers decide an appropriate treatment plan,” 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