Blog

- February 18, 2026

FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens

SANTA MARIA, Calif. and GUIPRY, France, Feb. 18, 2026 /PRNewswire/ — In a major step forward against Antimicrobial Resistance (AMR), NG Biotech, in partnership with Hardy Diagnostics, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designations to two rapid diagnostic assays: NG-TEST® Candida auris and NG-TEST® Acineto-5®. The designation recognizes technologies with the potential to address life-threatening conditions and significant unmet medical needs.

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Machine-learned biomarker identifies those at high risk for liver cancer

Researchers led by Xian-Yang Qin at the RIKEN Center for Integrative Medical Sciences (IMS) in Japan have developed a score that predicts the risk of liver cancer. Published in the journal Proceedings of the National Academy of Sciences, the study establishes that the protein MYCN drives liver tumorigenesis, specifically of the type of tumors found in the deadliest subtype of liver cancer.

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Stopping fatal blood loss with clay

Traumatic injury is the third leading cause of death in the state of Texas, surpassing strokes, Alzheimer’s disease and diabetes, according to the Centers for Disease Control and Prevention. A massive number of these deaths are the result of uncontrolled bleeding. “Severe blood loss can rapidly lead to hemorrhagic shock,” said Dr. Akhilesh Gaharwar, a biomedical engineering professor at Texas A&M University. “Many patients die within one to two hours of injury. This critical period is often referred to as the ‘golden hour.'”

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Kirigami-inspired sensors precisely map activity of neurons in the primate brain

Recent technological advances have opened new exciting possibilities for the development of smart prosthetics, such as artificial limbs, joints or organs that can replace injured, damaged or amputated body parts. These same advances are also enabling the development of other systems that connect the brain with machines, to record the activity of neurons or allow humans to operate machines in entirely new ways.

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