Boston Scientific received FDA approval for its navigation-enabled Farawave Nav ablation catheter and clearance for new ...

Thermo Fisher's Greenville, N.C. plant has been found in breach of US FDA regulations, including twice this year FDA's most recent inspection of Thermo Fisher plant found shortfalls in ...

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health ...

Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our ...

The following is attributed to Robert M. Califf, M.D., FDA Commissioner, and Jim Jones, Deputy Commissioner for Human Foods and Michael Rogers, Associate Commissioner for Inspections and ...

The FDA has granted a de novo clearance to Pi-Cardia’s ShortCut device, designed to open up previously implanted heart valves and clear a path for blood to flow into the coronary arteries ...

The FDA has previously granted Breakthrough Device ... which will be submitted with the expected near-term receipt of MDSAP certification.” Ticagrelor is a blood thinning drug frequently ...

MDL requires MDSAP certification, which the Company expects to receive shortly, at which point it will file its MDL application. Final regulatory decisions on DrugSorb-ATR are expected from FDA ...

The U.S. Food and Drug Administration (FDA) has approved flurpiridaz F-18 (Flyrcado; GE Healthcare), a first-of-its-kind positron emission tomography (PET) imaging agent, for use in adult patients ...

26, when the U.S. Food and Drug Administration (FDA) approved Cobenfy for the psychiatric disorder. Developed by Karuna Therapeutics, which was subsequently acquired by Bristol Myers Squibb ...

It is a severe, chronic mental illness that is often damaging to a person's quality of life," said Dr. Tiffany Farchione, director of psychiatry in the Office of Neuroscience in the FDA's Center ...