Baxter International Inc. has struck a definitive agreement to acquire Cheetah Medical Inc., a provider of noninvasive hemodynamic monitoring technologies. The Deerfield, Ill.-based company agreed to pay $190 million up front in cash, with the potential for an additional $40 million based on clinical and commercial milestones.

The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.

Concussion and traumatic brain injury (TBI) are serious public health problems, but they can be tricky to diagnose, with symptoms sometimes not presenting for days or weeks following a head injury. Abnormal eye movement can indicate a TBI, but traditional "follow my finger" screenings won't pick up more subtle changes in vision. Artificial intelligence (AI) could improve diagnosis by measuring deficits in certain eye movements that occur with a TBI. In a study published online July 25, 2019, in the journal Concussion, Bethesda, Md.-based Righteye Inc.'s FDA eye-tracking technology not only identified but scaled the severity of TBIs by measuring horizontal and vertical saccades, rapid eye movements between fixed points.

Screening for early signs of cognitive impairment and dementia amongst the elderly is a task that's often unevenly attended to by primary care physicians. But the routine personal consumer devices that we use every day might offer a clearer and more consistent window into early declines in cognitive and memory function, according to data from a feasibility study that were reported this week at the Association for Computing Machinery's Knowledge, Discovery and Data Mining conference in Anchorage, Alaska.

Deep learning algorithms developed at the Memorial Sloan Kettering Cancer Center (MSK) were able to distinguish prostate, skin and breast cancer with nearly perfect accuracy in a recent clinical trial. The technology has already been licensed exclusively by New York-based startup Paige.AI, which snapped up a $25 million series A early last year to continue to advance it.

PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.

PARIS – Six months after floating on the Euronext stock exchange in Paris, Predilife SA from Villejuif, France, is launching the Mammorisk predictive test for breast cancer risk in Europe and the U.S. "Mammorisk is the first multi-criteria test to use data mining, allowing it to combine medical imaging, genetic profile and family history," Pierre Verdet, assistant managing director of Predilife, told BioWorld MedTech.

Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA, making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.