The U.S. FDA granted breakthrough device designation to startup Brainspec Inc. for its non-invasive virtual brain biopsy system. The company uses standard magnetic resonance imaging equipment to measure brain chemistry rather than to create images, providing a more detailed view of pathophysiology involved in a range of neurological disorders. Read More
Payers are known to have a significant burden in crafting coverage and reimbursement policies for in vitro diagnostics, but Gillian Hooker, chief scientific officer at Concert Genetics Inc., of Nashville, Tenn., told an audience at the Next Generation DX Summit that the dilemma may be more expensive than commonly appreciated. Hooker said administrative costs may add as much as $125 per administered test, an artifact of a fragmented value chain that seems to enjoy few, if any prospects of improvement in the near term. Read More
Founded in 2014, Bertis Co. Ltd. is developing proteomics-based diagnostics and biomarkers by combining artificial intelligence/machine learning (AI/ML) algorithms with high-performance mass spectrometry technology. Using this technology, it is able to quantify extremely small amounts of protein. Read More
Cumulus Neuroscience Ltd. published a study demonstrating its home use electroencephalogram (EEG) can turn in more precise results than supervised laboratory-based assessments. Read More
Treating mice with butyrate, a short-chain fatty acid that is normally produced by beneficial gut microbes, prevented anaphylactic shock in allergic mice when they were exposed to peanuts after treatment. It also reduced inflammation in animals with colitis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Imperative Care, Tokyo Institute of Technology, Zetroz Systems. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bluerock, Biocardia, Cue Health, Fresenius, Glaukos, Incarda, Iveena, Labcorp, Physiq. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brain Scientific, Brainspec, Cordx. Read More
