MassDevice

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

Home » FDA clears Fresenius’ next-gen portable automated peritoneal dialysis system

FDA clears Fresenius’ next-gen portable automated peritoneal dialysis system

By

Fresenius Medical Care Versi PD dialysis cycler
The Versi PD is a portable automated peritoneal dialysis (APD) system designed to be light, simple, quiet and portable. [Image from Fresenius]
Fresenius Medical Care announced today it received FDA 510(k) clearance for its next-generation Versi PD cycler system.

The company designed the portable automated peritoneal dialysis (APD) system (from Fresenius Medical Care North America) as a light, simple, quiet, portable and advanced platform for improving health equity by making home therapy a more feasible option for a broader population of dialysis patients.

According to a news release, FDA clearance makes the Versi PD cycler system the lightest, smallest and quietest dialysis cycler in the U.S.

The company developed VersiPD to allow patients to enjoy restful sleep through its near-silent operation, with fewer disruptive alarms and a night mode option. The cycler also has the capability of more personalized prescription programming to meet the individual needs of a wide range of patients.

VersiPD includes a touchscreen and embedded videos with audio guidance to assist patients through each step of setup and treatment.

Fresenius plans a limited rollout for VersiPD in 2022, with more widespread availability expected in 2023 and beyond.

“The clearance of VersiPD is another important step in our effort to make home therapies easier for patients and more efficient for clinicians,” Fresenius Medical Care North America’s Renal Therapies Group President Joe Turk said in the release. “We have listened closely to what patients and clinicians want in a home dialysis experience and have brought those ideas into the heart of this innovative system.”

In case you missed it

RSS From Medical Design & Outsourcing

  • Zimmer Biomet narrowly avoids shareholder rebuke on executive pay
    An unusually large share of Zimmer Biomet (NYSE:ZBH) investors voted against the orthopedics company’s pay packages for top executives at the annual shareholder meeting. About 54% of voting shareholders supported the pay packages of the company’s five top-paid executives at the May 13 meeting, according to results filed with the SEC yesterday. In 2021, nearly 93%… […]
  • BD, Mitsubishi Gas Chemical partner on better materials for plastic syringes
    BD (NYSE:BDX) announced that it partnered with Mitsubishi Gas Chemical Company on applying new technology to pre-fillable syringes. MGC develops the Oxycapt technology designed to integrate the best of plastic and glass for plastic syringes. BD and Tokyo-based MGC will work together to apply Oxycapt technology to the next generation of pre-fillable syringes (PFS) for advanced… […]
  • Ambu replaces CEO with new leadership
    Ambu today said it has hired board member Britt Meelby Jensen to replace CEO Juan Jose Gonzalez, effective tomorrow. “Since Juan Jose Gonzalez joined as CEO in 2019, Ambu has made good progress and achieved important milestones on the strategic transformation into the world’s largest single-use endoscopy company,” Ambu Chair Jørgen Jensen said in a… […]
  • AdvaMed joins Biden’s Joint Supply Chain Resilience Working Group
    AdvaMed executive Abby Pratt has joined the executive committee for the Biden administration’s Joint Supply Chain Resilience Working Group, the medtech industry association said today. The working group’s members from government and industry will assist with implementation of the National Strategy for a Resilient Public Health Supply Chain. Pratt oversees supply chain issues as SVP… […]
  • Toray develops new stretchable film for medical devices
    Toray Industries has a new stretchable film based on its proprietary polymer Reactis technology, with potential applications that include robotics and biological and industrial sensors. Tokyo-based Toray said it shipped samples to customers and plans research and development efforts to commercialize the new grade of film. “Recent years have increased the potential for developing stretchable… […]
  • Google Health hires FDA’s chief digital health officer
    Former FDA Chief Digital Health Officer of Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency. Patel became senior director, global digital health strategy and regulatory for Google Health earlier this month, he said on LinkedIn. Patel recounted highlights of his “incredible journey since… […]
  • Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
    Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body. What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection,… […]
  • FDA moves forward with Voluntary Improvement Program to bolster medical device quality
    Kathryn Burke, Emergo Group The U.S. Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program. The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018.… […]
  • How Minnetronix Medical helped Lazurite with its wireless surgical camera
    Minnetronix Medical (St. Paul, Minnesota) has played an important development and manufacturing partner role with Lazurite’s wireless surgical camera system. It’s been nearly two months since Lazurite (formerly Indago) announced FDA 510(k) clearance of its ArthroFree system. ArthroFree combines proprietary low-heat, high-intensity Meridiem light engine technology with advanced camera, battery and wireless transmission technologies and… […]
  • Instron releases TrendTracker data analysis workflow platform
    Instron announced that it released the TrendTracker module in Bluehill Central for accelerating data analysis workflows. Norwood, Massachusetts-based Instron designed TrendTracker with an intuitive interface to improve the data analysis workflow of single or multi-location materials testing laboratories. According to a news release, the platform features quick searching and the ability to display and analyze… […]
  • Henry Schein hires former Medline veteran to drive ‘One Distribution’ push
    Henry Schein (Nasdaq:HSIC) today named Dirk Benson as VP and chief commercial officer of the medical device manufacturer and distributor’s North America Distribution Group (NADG). Melville, New York-based Henry Schein is the world’s largest provider of health care supplies and services for office-based dental and medical practitioners, and NADG is the company’s largest business group. The… […]