The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS examines device classification process at FDA; NIH offers NGS system for SARS-CoV-2; FDA issues pandemic policy for coagulation systems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine Research, Novaerus, Perkinelmer, Perspectum.
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of brain diseases; Predicting survival of COVID-19 patients; New causal gene for chronic kidney disease.
Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Excalibur Healthcare Services, Siemens Healthineers, Vestibular First.