Dxcover Ltd. initiated three pivotal trials to measure the efficacy of its liquid biopsy platform for early detection of brain, colorectal and lung cancers. The company hopes the trials will provide the evidence needed to gain regulatory approval and begin commercial operations of its diagnostic technology in Europe and the U.S.
In a potential godsend for women struggling with infertility and painful periods, Hera Biotech Inc. acquired the endometriosis diagnostic assets of Scailyte AG, consolidating the two leading tissue-based diagnostic programs for the disease. The combination of the companies’ non-surgical diagnostic options could significantly speed time to treatment for millions of women, who on average spend 10 years in search of the cause of chronic pelvic pain before being diagnosed with endometriosis.
Sometimes a small change of wording has a big effect on the implications of a U.S. FDA guidance, a notion that may apply to the U.S. FDA’s final guidance for the use of computational modeling in device premarket submissions.
A team of inventors predominantly based in the state of New York are seeking patent protection for an earbud system that integrates real-time electroencephalography (EEG) monitoring with audio playback. Using specialized silicone electrodes, it captures and interprets EEG data, serving as a passive and continuous tool for screening neurological conditions.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Bostongene, Caresyntax, Curonix, Cytek, Gimmi , Onward Medical, Novocure, Orthofix Medical, Painteq, Rescale, Sure Med, Total Scope, MC Healthcare, Vysioneer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bone Health Technology, Danaher.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bloomlife, Dermasensor.