Just a few short weeks after Uptake Medical (Tustin, California) reported the first commercial use in Europe for its InterVapor System the small med-tech company is revealing that it has garnered approval for the device in Australia.
While there haven't been any firm estimates on the off-label use of devices treating atrial fibrillation (AF), the fact remains that this is a strong concern for the FDA especially since in the past there haven't been any devices specifically approved for this indication. That's changed recently, as AtriCure (West Chester, Ohio) reported that it has gained FDA approval for its Synergy ablation system for the treatment of AF.
Fresh off a rebranding of its product, ETView (Tel Aviv, Israel) is reporting that it has filed an application to secure 510(k) approval from the FDA for its VivaSight DL Airway Management System.