Getinge Sees Q1 Acute Care Orders Jump 96%, Plans Major Investment In ECMO
The Swedish company has seen a spike in orders of acute care products to treat COVID-19 patients and plans a multi-million investment to expand long-term ECMO production.
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Data from the Extracorporeal Life Support Organization registry shows experienced centers should consider using extracorporeal membrane oxygenation to treat COVID-19-related respiratory failure.
COVID-19: String Of FDA Guidance Docs Lay Bare Enforcement Policies For Infusion Pumps, ECMO Devices, Thermometers, And More
In three separate immediately-in-effect guidance documents, the US agency says makers of infusion pumps and accessories, extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices, and remote ophthalmic assessment and monitoring devices can make “limited modifications” to those products so they can be used during the ongoing novel coronavirus crisis, without the need for firms to seek out a new 510(k). A fourth guidance says clinical electronic thermometers that aren’t yet 510(k)-cleared by the FDA can be distributed for use.
Production of ventilators is up by tens of thousands of units across Europe, but the supply chain is likely to come under strain with further expansion.