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The FDA highlighted the need for long-term neurodevelopmental studies by sponsors of neonatal medical products —whether a drug, biologic product or device — in a new draft guidance released Friday.
The FDA has issued a warning letter to Nendingen, Germany-based laparoscopy devicemaker Getsch+Hiller Medizintechnik (GH) for unapproved product changes, the lack of a design history file and other lapses observed during a July 2022 inspection.
GE Healthcare is acquiring Caption Health, a California-based company that uses artificial intelligence (AI) solutions for early detection of heart disease in ultrasound scans.
aragonix Technologies’ LUNGguard donor lung preservation system recently saw its first use for a pediatric case in which donor lungs procured overnight were preserved with the system, allowing for next day transplant surgery.
Abbott is expanding its portfolio of cardiovascular devices through an $890 million purchase of St. Paul, Minn.-based Cardiovascular Systems (CSI) and its orbital atherectomy system.
A jury in the U.S. District Court for the Central District of California has awarded cardiac devicemaker Colibri Heart Valve $106.5 million for infringement by Medtronic’s CoreValve devices of Colibri’s patents for a self-expanding valve device used to replace diseased heart valves.