The FDA just fast-tracked a device that clears blood from the brain's fluid after a bleeding stroke
When an aneurysm — a weakened spot in a brain blood vessel — bursts, blood spills into the fluid that cushions the brain, and the breakdown products of that blood can themselves cause further injury in the days that follow. Pharaoh Neuro's Neurapheresis system is designed to filter that fluid and remove the blood and its breakdown products faster. This week the US Food and Drug Administration granted the system Breakthrough Device Designation — a programme that gives promising devices for serious conditions more frequent, interactive review so they can reach patients sooner — and accepted it into its Total Product Lifecycle Advisory Program. 'The designation validates our belief that Neurapheresis offers significant advantages over existing approved or cleared alternatives,' said chief executive Amaza Reitmeier. 'We look forward to working with the agency to bring this technology to patients as quickly as possible.' The device is not yet approved; the designation is a faster lane, not a finish line.
SDG 3 · Good health and well-being — Mechanism: tech innovation