FDA Pulls Another COVID-19 Rapid Antibody Test Over Performance Concerns
Autobio’s test reportedly only correctly identified half the positive SARS-CoV-2 antibody samples in an NIH evaluation.
Autobio’s test reportedly only correctly identified half the positive SARS-CoV-2 antibody samples in an NIH evaluation.
Medtronic has secured coverage to market its recently approved MiniMed 780G insulin pump to eligible Medicare and Medicare Advantage beneficiaries, opening access to more patients…
Tandem Diabetes Care received US FDA clearance for its Mobi insulin pump and expects a limited rollout by year-end.
Dexcom wins Health Canada approval to market its G7 CGM in Canada, following announcements of its ambitious R&D map to expand into metabolic health and…
Public and private payors at the Digital Therapeutics Alliance’s 2023 Inaugural Summit weighed in on the coverage environment for prescription digital therapeutics post-Pear Therapeutics and…
Medtronic announced data at the ADA conference today showing the MiniMed 780G advanced hybrid close loop system’s meal detection technology helps reduce time spent in…
The US FDA has released a draft guidance from the International Council for Harmonisation that aims to modernize clinical trials. The agency is requesting feedback…
The CEOs Reimagine Care, Cortica and Inbound Health, part of the rising trend to bring specialty and acute care programs into the home, joined a…
The FDA cleared Thermo Fisher’s in vitro diagnostic for preeclampsia, the leading cause of pregnancy morbidity and mortality, based on results from the PRAECIS study.
A patient says Cleerly’s innovative technology revealed underlying heart disease that had previously gone undetected. The company’s founder weighs in on the results.
Siemens Healthineers and GE HealthCare are among industry leaders blazing a trail to a digitally connected, AI-powered healthcare future.