Pulmonx is almost ready to submit the results of the pivotal LIBERATE trial of its Zephyr endobronchial valve to the US FDA. The data will support a premarket approval and the company hopes to bring the device, along with the Chartis patient-selection system, to the US market in 2018.
Pulmonx Corp. believes it is close to finally earning US FDA approval for its Zephyr endobronchial valve, nine years after the agency rejected it and almost 20 years since it was first developed.
The Zephyr is a small silicone-covered stent-valve installed in the lungs via a minimally invasive procedure to block airflow to...
SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.
