Auxein, an innovator in orthopaedic solutions, becomes the first Asian company to achieve EU-MDR certification for its trauma ...

BusinessWire India New Delhi [India] October 19 Auxein a global innovator in orthopaedic and arthroscopy solutions is proud ...

PRINCETON, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery ...

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 ...

"With the FDA approval last week, we are experiencing high demand for Motiva Implants ? both from surgeons and patients," said Juan José Chacón-Quirós, Founder and Chief Executive Officer of ...

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 ...