GE HealthCare has gained 501(k) clearance from the US Food and Drug Administration (FDA) for its CleaRecon DL technology, as well as a European CE Mark. An AI-based technology for improving the ...

Spectrumedics joins J&J MedTech’s Shockwave and Elixir Medical as the only other companies with EU-approved IVL systems.

Abbott’s range of paediatric heart treatments also includes the Masters HP 15mm mechanical heart valve. Credit: Michael Vi / Shutterstock.com. Abbott has secured the US Food and Drug Administration ...

Paris, France and Cambridge, Massachusetts-based Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes ...

This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

CMR Surgical announced today that it received CE mark and UK approval for its Versius surgical robot in pediatric surgery.

FDA 510(k) application submitted to allow marketing of the ARC-EX ® System for home use in the United States CE Mark application filed with notified body to enable commercialization of the ARC-EX ...

LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, today announced it has received the U.S. Food and ...

Abbott has secured the US Food and Drug Administration (FDA) and CE Mark approvals for its Amplatzer Piccolo delivery system, designed for premature infants diagnosed with patent ductus arteriosus ...