The ECRI Institute identified these issues as the biggest patient safety concerns in 2019. Can medtech help tackle them?
The new diagnostic assay format could provide a means of performing low-cost tests for particular strains of flu at the point of care, but there are challenges to address.
Product launches, study results, and approvals were signs of a pretty significant week in diagnostics, as FDA, CMS, and CDC formed a task force to make diagnostics rapidly available during public health emergencies.
Influenza and its complications cause as many as 140,000 to 710,000 hospitalizations and 12,000 to 56,000 deaths annually in the U.S.
Indiana University of Medicine researchers said the test can help identify biomarkers in the blood and could actually help in the fight against opioid abuse.
The research behind the development of the test was supported by the National Institute of Allergy and Infectious Diseases, part of NIH.
Biodesix and MRM are the latest diagnostic firms to enter into a partnership geared at the early detection of lung cancer.
In addition, the company said it has received a breakthrough device designation for the test, which predicts amyloid PET scan results in patients.
Day Zero Diagnostics has raised $8.6 million to further develop a sequencing-based rapid diagnostic that identifies, within hours, both the species and the antibiotic resistance profile of a bacterial pathogen.
The Mountain View, CA-based company received a nod from FDA for the MUTYH-Associated Polyposis Genetic Health Risk report.
The donor-derived cell-free DNA test was developed by the National Institutes of Health/National Heart Blood and Lung Institute.
The test, developed by Researchers at the Institute for Global Food Security at Queen’s University Belfast, can detect proteases, enzyme markers that are responsible for the progression of many diseases.
The first donor-derived cell-free DNA test to assess allograft health in kidney transplant patients is also beneficial for repeat transplant recipients, a new study finds.
The Boulder, CO-based company has been granted a Breakthrough Device Designation for its liquid biopsy and tissue specimen assay.