Medtronic Wins In England’s NICE Decision On Implantable Monitors For Stroke Patients; Biotronik And Abbott Lose
UK health technology assessment body NICE says that Medtronic’s Reveal LINQ, which transmits data remotely to doctors, is likely to be a cost-effective use of National Health Service resources.
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FDA Clears Medtronic's And Boston Scientific's Remote Cardiac Monitors, Approves Abbott’s Bluetooth-Compatible ICDs
Medtronic will launch the LINQ II remotely programmable, insertable cardiac monitor in the US and Europe this summer following FDA clearance. Boston Scientific plans to launch its LUX-Dx monitor later this year. The agency also approved Abbott's Gallant ICD and CRT-D devices, which communicate with Abbott's myMerlinPulse mobile app.
Vertex and CRISPR can now get access to the advantages afforded by the European Medicines Agency’s priority medicines scheme for both of the indications they are targeting with their investigational gene therapy, CTX001.
The UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.