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The biomarker software can help physicians direct patients into certain treatment courses or target enrollment for clinical trials, the company said. Read More
Early results from a clinical study showed a significant improvement in patients’ quality of life and an improvement in their sleep quality, the company said. Read More
A proposed in vitro diagnostics reform bill that may end up in legislation reauthorizing device user fees could have a chilling effect on the development of infectious disease-specific tests, warns the American Society for Microbiology (ASM). Read More
Parsippany, N.J.-based Extremity Medical has filed a federal patent lawsuit against competitor Fusion Orthopedics, claiming that the company, which was cofounded by a former Extremity sales representative, is infringing on two of its patents. Read More
The FDA has given Class I designation, the highest level of risk, to Avanos Medical’s March 21 recall of its Cortrak*2 enteral access system because of the potential for serious patient injury or death if the device is misused. Read More
The new assay is the first in a series of planned quantitative assays to support patient care following transplant surgery, the company said. Read More