Devices

First Light’s C. Difficile Test Cleared

FDA has cleared a First Light Diagnostics 510(k) for its SensiTox C. difficile toxin test along with its proprietary MultiPath Analyzer. C.difficile causes more life-threatening hospital infections than any other pathogen and is considered by the CDC to be an urgent antibiotic resistance threat, according to the company.

The test uses the company’s MultiPath technology for “single molecule counting to ultrasensitively detect toxins and biomarkers at much lower levels than most rapid tests on the market,” First Light says. The clearance was based on data from a clinical study conducted at three sites in the U.S. that included more than 1,000 specimens. “In this study, the test was shown to have excellent clinical sensitivity and specificity,” it says, adding that the test delivers a result in 35 minutes on the MultiPath Analyzer, an automated benchtop system with high throughput and continuous random access loading of specimens.

Additionally, the company says it is developing a group of products to provide rapid generation of antimicrobial susceptibility test results, enabling clinicians to prescribe the optimal targeted, narrow-spectrum therapy in hours instead of the days it currently takes. The first test under development is the UTI-Direct test for detecting urinary tract infections and determining the best antibiotic treatment.

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