The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.
CAJICA, Colombia –The government of Costa Rica issued guidelines recently that will allow the country’s social security system to source the country's hospitals with ventilators produced by the faculties of the universities of the Latin American country, during the COVID-19 outbreak.
PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosense Webster, Setpoint Medical.
Keeping you up to date on recent developments in oncology, including: New data cast doubt on post-resection radiotherapy for NSCLC; Carcinogens need not be mutagens; Myelin regulatory factor assists pancreatic cancer cells; Deepmedic provides glioblastoma segmentation with sparsified data.