LOUISVILLE, Ky., Feb. 19, 2026 /PRNewswire/ — Breath Diagnostics, Inc., a leader in breath-based molecular diagnostics powered by patented microreactor capture technology, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its OneBreath™ platform.
CHICAGO, Feb. 19, 2026 /PRNewswire/ — Sibel Health, a leader in medical-grade wearable sensor technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s recent Letter of Intent (LOI) into the Clinical Outcome Assessment (COA) Qualification Program under the Drug Development Tool (DDT) framework. The acceptance marks a significant milestone in advancing objective cough frequency measurement for adult patients with chronic refractory cough (CRC) using a novel Cough Monitoring sensor, the Aria sensor.
As aging populations and rising diabetes rates drive an increase in chronic wounds, more patients face the risk of amputations. UC Riverside researchers have developed an oxygen-delivering gel capable of healing injuries that might otherwise progress to limb lo
Researchers at the Icahn School of Medicine at Mount Sinai have reported promising findings that may help redefine treatment for patients with muscle-invasive bladder cancer, a potentially aggressive form of the disease traditionally treated with surgical removal of the bladder. The study, published in the Proceedings of the National Academy of Sciences, demonstrates that ultra-sensitive testing of tumor-derived DNA in blood and urine may help identify patients who can safely preserve their bladder without compromising cancer outcomes.
A pioneering genetic test is improving early diagnosis and treatment for people with hereditary cancer caused by a genetic condition. The test, developed with the help of Newcastle University scientists, identifies specific signs in a person’s DNA that are characteristic of cancers linked with Lynch syndrome.
A research team investigating the use of the bacterium Listeria monocytogenes against colorectal cancer has discovered a way to build a modified version of Listeria as an oral vaccine to prime the immune system directly within the gut, where anti-tumor cells are then generated. Details of the work, led by Stony Brook immunologist Brian Sheridan, Ph.D., are published in the Journal for the ImmunoTherapy of Cancer.
The eyes—specifically, the outer area of the retina—may provide a window into early detection of Alzheimer’s disease (AD) long before irreversible brain damage has occurred, according to new research from Houston Methodist. This discovery could dramatically change how the disease is diagnosed, monitored and treated.
A new electronic implant system can help lab-grown pancreatic cells mature and function properly, potentially providing a basis for novel, cell-based therapies for diabetes. The approach, developed by researchers at the Perelman School of Medicine at the University of Pennsylvania and the School of Engineering and Applied Sciences at Harvard University, incorporates an ultrathin mesh of conductive wires into growing pancreatic tissue, according to a study published in Science.
Now, researchers from the University of Southern Denmark and Odense University Hospital have discovered a previously undescribed virus in a common gut bacterium. The virus appears more frequently in patients with colorectal cancer. The study is published in the journal Communications Medicine.
Researchers at Washington University School of Medicine in St. Louis have developed a method to predict when someone is likely to develop symptoms of Alzheimer’s disease using a single blood test. In a study published in Nature Medicine, the researchers demonstrated that their models predicted the onset of Alzheimer’s symptoms within a margin of three to four years.