Global Device Approvals Snapshot: 28 May-3 June 2019
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week’s approvals include the US FDA's approval of a panel-track supplement for TransMedics' OCS Lung system to preserve donor lungs that would not be salvageable using a traditional cold static system.
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SugarBEAT is a non-invasive, needle-free, disposable adhesive skin-patch connected to a rechargeable transmitter. The company says it is the world’s first non-invasive continuous glucose monitor.
FDA approved a PMA supplement to allow TransMedics' Organ Care System (OCS) to be used for the preservation and ex-vivo assessment of lungs that would not be acceptable for transplant if they had been preserved with a standard cold static system.
Israel-based exoskeleton company ReWalk Robotics Ltd. announced it received a CE mark for its next-gen ReStore Exo-Suit for stroke rehabilitation, paving the way into a larger patient population.