MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Edwards Lifesciences wins FDA nod for ClearSight monitor

Edwards Lifesciences wins FDA nod for ClearSight monitor

By

Edwards Lifesciences wins FDA nod for ClearSight monitor

Edwards Lifesciences (NYSE:EW) said today that the FDA granted 510(K) clearance for its ClearSight patient monitoring system.

The non-invasive device is designed to provide blood volume and blood flow data for patients "at moderate or high risk of post-surgical complications, in whom invasive monitoring would not be used," according to a press release.

"The ClearSight system is the most advanced noninvasive monitor of its kind. This important development in the field of critical care medicine builds on Edwards’ 40 years of experience in providing clinicians with tools to make more informed decisions that can advance patient care by helping to reduce complications, shorten hospital stays and lower associated costs," critical care and vascular vice president Carlyn Solomon said in prepared remarks.

Edwards said the ClearSight device has also been granted CE Mark approval in the European Union.

"Proper intraoperative management of moderate and high–risk surgery patients is critical to help reduce the risk of post–surgical complications," Dr. Julie Thacker of the Duke University Hospital said in a statement. "Studies have indicated that patient outcomes are improved through monitoring and management of vital hemodynamic information through hemodynamic optimization protocols."

In case you missed it

RSS From Medical Design & Outsourcing

  • Smith+Nephew expands reach of its Cori handheld robotic system
    A year after Smith+Nephew (NYSE:SNN) launched its Cori handheld robotic system in the U.S.,  the ortho surgery system has launched globally. The British medtech giant has expanded Cori’s reach to Europe, Australia and New Zealand, India, and Canada (just announced today). The company yesterday said the system was now available for use in the U.K.’s National Health… […]
  • Elizabeth Holmes reportedly expresses remorse in criminal fraud trial
    Elizabeth Holmes reportedly revealed some regret over her handling of business as the ex-Theranos CEO took the stand again in a criminal fraud trial. Taking the stand yesterday for the third day of testimony in federal court in San Jose, California, Holmes was said to have shown remorse while still shifting some of the blame… […]
  • Supply chain, manufacturing issues slow Medtronic’s Hugo launch, ramp-up expected next fiscal year
    Medtronic (NYSE:MDT) Chair & CEO Geoff Martha confirmed that the launch of the Hugo surgical robot platform is off-schedule. Hugo received CE mark approval last month. The company is gearing up to conduct its FDA investigational device exemption (IDE) clinical trials in the U.S., with more on its stateside efforts still to come, Medtronic’s surgical robotics… […]
  • Minnetronix Medical honored in Minnesota for its MindsEye Expandable Port
    Minnetronix Medical (St. Paul, Minn.) received an award from the Minnesota Technology Association that highlights its MindsEye Expandable Port for minimally invasive deep brain access. The company won the association’s TEKNE award for best medical technology and devices. “Given Minnesota is a global epicenter for the medical device industry, this award is quite meaningful to Minnetronix… […]
  • BD expands biosciences business with reagent innovation center in San Diego
    A life sciences real estate developer announced today that BD (NYSE:BDX) selected its property as a new facility for its biosciences business. Through a joint venture with Tishman Speyer and Bellco Capital, Breakthrough Properties confirmed that BD chose its Torrey View by Breakthrough property for an expanded San Diego reagent innovation center within its biosciences… […]
  • The best places to work for medtech sales reps in 2022
    Teleflex (NYSE:TFX), ConMed (NSDQ:CNMD) and Medtronic (NYSE:MDT) topped the list of best places to work in medtech sales in 2022, according to a MedReps.com survey of medical sales representatives. The 11th annual MedReps survey polled over 2,300 MedReps professionals to determine which medtech sales companies are most sought-after in the industry. Overall, pay and leadership were the most… […]
  • How medtech fared in the first waves of the pandemic
    Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data. Total sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying… […]
  • FreeStyle Libre 3, other Abbott products recognized at CES Innovation Awards
    Abbott (NYSE:ABT) was honored for a handful of its offerings at the Consumer Electronics Show (CES) 2022 Innovation Awards. The company’s FreeStyle Libre 3 continuous glucose monitoring (CGM) system ranked among the top 15 products in the CES Best of Innovation category. The next-generation CGM system features the world’s smallest, thinnest glucose sensor that can… […]
  • Evonik launches new Resomer PrintPowder polymers for 3D printing of personalized, implantable medical devices
    Evonik has launched the second generation of Resomer PrintPowder polymers for 3D printing of personalized, implantable medical devices. Essen, Germany-based Evokik said the powders have a broader range of customizable mechanical properties and degradation rates, allowing their use for more complex and tailored medical devices including orthopedic, dental, or soft tissue applications. “These new powders… […]
  • Tungsten cable for surgical robotics: Challenges solved introduce new unsolved challenges
    Tungsten cable is the perfect strength, flexibility, and diameter for surgical robots. Connor Chiuchiolo and Scott Dailey, Carl Stahl Sava Industries When manufacturing tungsten mechanical cable for surgical robotics, the tungsten itself presents enormous mechanical upside, including extraordinary tensile strength captured within astonishingly small diameters. What’s more, tungsten stranded into ultrafine mechanical cable possesses a remarkable… […]
  • FDA says Philips knew about toxic foam for years before massive recall
    The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices. The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam… […]

Leave a Reply