Molecular diagnosis is performed at the gene level with nucleic acids as the object for detection, with high sensitivity and accuracy.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Castle Biosciences reported after the close of the market recently that its third quarter revenues skyrocketed 300 percent year over year due to growth in the firm's DecisionDx- Melanoma test report volume.

Liquid biopsy firm Lexent Bio recently announced a non-exclusive partnership with Illumina to develop an in vitro diagnostic kit for cancer.

Duke University Researchers have developed a new detection tool that uses tiny circuits made of DNA to identify cancer cells. The researchers fashioned the simple circuits from interacting strands of synthetic DNA that are tens of thousands

Renovia has received a nod from FDA for a next-generation pelvic digital therapeutic. The Boston-based company said the Ieva device is cleared for the strengthening of pelvic floor muscles and the treatment of stress, mixed, and mild to mode

Patients interested in testing themselves at home for sleep apnea now have a few more options.

Medtronic filed an amendment Tuesday to its lawsuit against Axonics Modulation Technologies, adding three more patent infringement claims to the suit. The original lawsuit, filed earlier this month, alleged infringement of four patents relat

FDA is encouraging manufacturers to reduce the amount of paper included in sterile device packaging in order to reduce the amount of ethylene oxide (EtO) required for effective sterilization. A new voluntary master file program also aims to

Trends toward wearable medical devices are growing, both in the consumer sector and in healthcare. “There are many trends, both in the hospital segments and consumer segments, and they go based on specific needs or wants—what the consume

Shutdowns earlier this year of two facilities that use ethylene oxide (EtO) to sterilize medical devices prompted FDA to monitor for supply shortages in the industry because EtO is such a popular sterilization method for medical devices. Thi

Attune Medical is hoping to get a label expansion for its device to reduce thermal injury to the esophagus during cardiac ablation procedures. The Chicago, IL-based company said its ensoETM device is being evaluated in several clinical studi