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Zynex has acquired Kestrel Labs for $31 million, adding the Boulder, Colo.-based company’s laser-based, noninvasive patient monitoring technology to its line of noninvasive devices for pain management and monitoring. Read More
Whatever ground the device industry lost due to the COVID-19 pandemic it has mostly regained, according to GlobalData, a UK-based market analytics company. Read More
Labcorp is buying Personal Genome Diagnostics for up to $575 million, gaining the Baltimore, Md.-based company’s elio range of liquid biopsy and tissue-based products. Read More
DSAART, a devicemaker doing business as Alpha Aesthetics, failed to investigate numerous complaints about its silicone facial and body contouring implants, the FDA said in a warning letter to the Carson City, Nev.-based company. Read More
FDA-authorized antigen tests for the virus that causes COVID-19 appear to work for the omicron variant but they may have less sensitivity for identifying positive samples, the agency said. Read More
For SARS-CoV-2, which causes COVID-19, LumiraDx’s test has a positive agreement of up to 95.5 percent and a negative agreement of up to 99.2 percent with RT-PCR tests, based on clinical data collected up to 12 days after symptom onset. Read More
The system’s biggest benefit is the “ability to assess the function of the organ on the device prior to committing to the transplant,” said the principal investigator for the trial that supported the FDA approval. Read More