Royal Philips (NYSE:PHG) said today it won CE Mark approval in the European Union for its Philips V60 Plus ventilator system.
The Netherlands-based company said that the newly cleared system features both noninvasive ventilation and high flow therapy, which allows the system to be used with changing patient conditions without having to switch devices.
The V60 is intended for early interventions into respiratory failure, Philips said, but is designed to deliver a wide range of non-invasive support for patients to lessen the challenge of weaning patients off of noninvasive ventilation.
“When treating respiratory patients in intensive and emergency care settings, it’s critical for clinicians to be able to wean efficiently or to quickly escalate care depending on their patient’s condition and specific needs. This often means complex workflows and alternating devices in time-sensitive situations. We are excited to offer a comprehensive noninvasive solution that enables quick therapy and interface transitions, so clinicians can focus on providing for their patients while spending less time setting up equipment,” Philips hospital respiratory care biz lead Jim Alwan said in a prepared statement.
Philips said that it is also seeking FDA 510(k) clearance for the system, and that it has already submitted to the agency.
“We are delighted with the high flow function of the V60 Plus. It saves us a lot of time and space as we can use the same equipment for both NIV and high flow. When you need to wean patients from NIV to HFT, it is very simple with the one device. Additionally, the cannula is high quality, easy to adjust, soft against the patient’s skin and V60 flow is much quieter than our standalone high flow system,” registered nurse Peter Lindberg of Stockholm, Sweden’s St. Goran Hospital said in a press release.
Last month, Philips said that it launched an all-in-one breast assessment solution designed for use with its Epiq and Affiniti ultrasound systems.
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