Florida / New York / No Carolina
Ph: 561.316.3330

Dräger Secures FDA 510(k) Clearance for Evita V600, V800 and Babylog VN800 Ventilators

Summation

  • “We developed the Evita and Babylog family of devices to meet customer demand for effective and safe mechanical ventilation that is both easy to use and cost-conscious,” said Steve Menet, Senior Vice President of Sales for Hospital Solutions at Draeger, Inc.
  • The glass touchscreen on the devices, as an almost seamless screen, also supports the daily hygiene routine at the intensive care workstation.
  • The user is guided through the individual menus with larger icons, important functions at the top menu level, and a clear, color-coordinated screen design.

Dräger announced today that it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the Evita V600, V800, and Babylog VN800, its newest devices for mechanical ventilation of adults to premature babies. Dräger has developed an operating concept that makes device orientation easier and provides clear user guidance. The user is guided through the individual menus with larger icons, important functions at the top menu level, and a clear, color-coordinated screen design. The lower number of colors for the screen elements and the reduced use of signal colors enable clear, smooth navigation. The bright screen background also minimizes disruptive reflections of ambient light. Clearly structured device checks help safely prepare for the next patient.

“We developed the Evita and Babylog family of devices to meet customer demand for effective and safe mechanical ventilation that is both easy to use and cost-conscious,” said Steve Menet, Senior Vice President of Sales for Hospital Solutions at Draeger, Inc. “This launch takes us a step closer to our goal of providing added value for clinical personnel and patients while simultaneously optimizing costs in the hospital.”

Proven ventilation technology protects patients

Over one hundred years of Dräger experience in ventilation flowed into the technology. It is the basis for efficient therapy options, which can simultaneously improve patient safety. The early support of spontaneous breathing can also help the patient regain mobility more quickly.

Infection prevention requirements considered

To maintain the infection management chain in the hospital, medical devices must support the requirements of hygienically sensitive areas in hospitals. As a result, the new Dräger ventilators not only have a rounded design with few edges and overhangs, but they also have surfaces that can be effectively disinfected. The glass touchscreen on the devices, as an almost seamless screen, also supports the daily hygiene routine at the intensive care workstation.

The Evita V600, Evita V800, and Babylog VN800 ventilators are manufactured by Drägerwerk AG & Co. KGaA.

Other FDA News of Interest

Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes

"Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans – particularly children and adolescents – across the country," said Acting Associate Attorney General Benjamin C. Mizer. "This interagency Task Force is dedicated to protecting Americans by combatting the unlawful sale and distribution of these products. And the establishment of this Task Force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority."

Tris Pharma Receives U.S. FDA Approval for Once-Daily ONYDA XR (clonidine hydrochloride) Extended-Release Oral Suspension, the First-and-Only Liquid Non-Stimulant ADHD Medication

ONYDA XR is indicated for the treatment of ADHD as monotherapy or as adjunctive therapy to approved CNS stimulant medications in pediatric patients six years and older. The first non-stimulant ADHD medication, with nighttime dosing, adds to Tris Pharma’s established portfolio of leading ADHD therapies and reinforces company's commitment to individuals with ADHD.

Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu Images Acquired with the NanoZoomer® S360MD Slide Scanner

Indica Labs, an industry leader in AI-powered digital pathology solutions, and Hamamatsu Photonics K.K., a pioneer in whole slide imaging systems, announce that the...

By using this website you agree to accept Medical Device News Magazine Privacy Policy