News UK seeks views on indefinite CE marks for medical devices The UK has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in GB should be recognised indefinitely.
News Abbott's wireless heart failure sensor cleared for NHS use A wireless sensor the size of a paperclip, Abbott's CardioMEMS HF, can now be used routinely by the NHS to monitor patients with heart failure.
News FDA clears first at-home device for depression Flow Neuroscience has secured FDA approval for FL-100, the first at-home brain stimulation device for major depressive disorder.
News J&J streamlines with plan to hive off orthopaedics unit Johnson & Johnson has said it wants to spin off its orthopaedics division as part of an effort to redirect its business towards higher-growth areas.
News European Commission approves 2nd IPCEI to sum of €403m The European Commission has approved, under EU State aid rules, the second health-related IPCEI to support innovations in medical devices.
News UK regulator overhauls medical device regulation Major changes to medical device regulations in the UK have come into force with an overhaul of post-market surveillance requirements.
News FDA approves higher Wegovy dose via 4th priority voucher The US FDA has approved a fourth product via its new National Priority Voucher Programme -- a 7.2 mg dose of Novo Nordisk's weight loss drug Wegovy (semaglutide), to be marketed as Wegovy HD.
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