Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biotricity, B-Secur, C2N, Concertai, Guardant, Silver Bullet, Zero Candida.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Oxford Brain Diagnostics, Prelude, Surgentec.
According to the World Health Organization (WHO), multidrug-resistant pathogens caused over 1.27 million deaths worldwide in 2020. And figures are rising, with projections pointing to antimicrobial resistance surpassing cancer as the leading cause of death by 2050. Now, researchers at the HUN-REN Biological Research Center have unveiled the role of pre-existing genetic variabilities and specific cross-resistance patterns among several antibiotics designed to combat gram-positive bacteria.
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
Natera Inc., a developer of cell-free DNA testing, provided an update on its product portfolio at the J.P. Morgan Healthcare Conference on Jan. 15. The company disclosed a new version of the Signatera assay that leverages the genome. Natera said the test, now available for research and clinical use, enables bespoke assay design from a whole genome sequence of a patient’s tumor.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alamar, Buttium, Firefly Neuroscience, GE Healthcare, Guardant, Helix, Henry Schein, Intech, Kryptos Biotechnologies, Lady Technologies, Microbix, Microsoft, My Own Med, Nextbiomedical, Nextstim, Nvidia, Pison, Resolve Surgical, Respondhealth, Sapient, Siemens Healthineers, Sinaptica, Smith & Nephew, Stmicroelectronics, Synchron, Tyber Medical, Vaxxas, Virtuoso, Visby, Viz.ai.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biobot Surgical, Icotec.
The Medicare coverage story of the Cardiomems device has a Homeric air about it, spanning nearly a decade starting with an adverse local coverage determination in 2016. Abbott Park, Ill.-based Abbott Laboratories finally brought the story full circle with a successful national coverage determination that gives the device nationwide coverage for Medicare patients without the need to wrangle with Medicare administrative contractors.