FDA clears 5008X hemodialysis system from Fresenius Medical Care

Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system.

The company said this marks a step toward bringing a new standard of care in dialysis therapy to the U.S. Bad Homburg, Germany-based Fresenius can now begin U.S.-based clinical evaluations and user studies ahead of a broad launch in 2025.

Fresenius’ 5008X system offers industry-leading, high-volume hemodiafiltration dialysis therapy. Along with the companion FX CorAL dialyzer, it combines the latest device engineering and cutting-edge membrane technologies. The company says these technologies make high-volume hemodiafiltration possible.

This method of dialysis incorporates both diffusion and convection techniques. It eliminates larger molecules and effectively manages fluid replacement through convection.

Fresenius Medical Care says a study demonstrated that its system provided a 23% decrease in mortality rates compared to those treated w…

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Fresenius notches AI milestone in clinical dialysis dataset

[Image courtesy of Fresenius Medical Care]Fresenius Medical Care announced the completion of phase one of its first anonymized global dialysis dataset as part of its long-term AI aspirations.

The Apollo database project aims to advance patient care quality and outcomes by making kidney disease care more personalized and precise. It provides a view into the clinical care provided to more than 540,000 dialysis patients. Fresenius Medical Care says it’s the largest multinational, longitudinal database of its kind.

Phase one of the Apollo database project harmonizes data from the company’s global clinical systems into the cloud. It aggregates data from 40 countries across six continents on more than 350 patient treatment parameters. The AI-powered project includes information on more than 140 million dialysis treatments and more than 34 million laboratory assessments.

“Artificial intelligence is only as good as the data that powers it,” said Dr. Fra…

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FDA clears software for Fresenius home hemodialysis system

The VersiHD system. [Image courtesy of Fresenius Medical Care]Fresenius Medical Care announced today that the FDA granted 510(k) clearance for its Versi HD with GuideMe software.

The completely reinvented, self-guided interface serves Fresenius’ VersiHD chronic home hemodialysis (HHD) system. It aims to transform the experience of HHD for both patients and nurses.

Fresenius Medical Care’s NxStage designed VersiHD with GuideMe to provide graphical walkthrough guidance. It enhances ease of use and confidence for patients and nurses while improving patient training time. The company says it eases the transition to home and makes the training experience easier for new users.

“With over 13,000 HHD patients in the U.S. alone, we are excited to amplify the innovation NxStage offers with advanced technologies, like VersiHD with GuideMe Software,” said Dr. Katarzyna Mazur-Hofsäß, CEO of Fresenius Medical Care’s Care Enablement segment. …

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Fresenius Medical Care stock dips on mixed Q2 results

Fresenius Medical Care (NYSE: FMS) + shares fell this morning on second-quarter results that came in mixed compared to the consensus forecast.

Shares of FMS were down 2% at $25.33 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell by nearly 1%.

The Germany-based dialysis company posted profits of $153.4 million. That amounts to 53¢ per share, on sales of $5.29 billion for the three months ended June 30, 2023.

Wall Street experts expected earnings per share of 31¢, but Fresenius just missed sales expectations of $5.33 billion.

Fresenius Medical Care recorded a 4.8% bottom-line slide on sales growth of 1.4%. The company attributed revenue growth to a favorable impact from the value-based care business, reimbursement rate increases and a favorable payor mix. A negative exchange rate effect partially …

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Fresenius Medical Care converts to German stock corporation to simplify corporate structure

Helen Giza at the Extraordinary General Meeting held by Fresenius Medical Care. [Image courtesy of Fresenius Medical Care]Fresenius Medical Care announced today that an Extraordinary General Meeting (EGM) saw shareholders approve a change to corporate structure.

The renal disease treatment product provider’s shareholders approved all EGM agenda meetings with a large majority. One major approval was the conversion of Fresenius Medical Care from the legal from of a partnership limited by shares into a German stock corporation.

Fresenius Medical Care elected the four shareholder representatives on the supervisory board of the new Fresenius Medical Care AG. Following the EGM, a constituting meeting of the supervisory board led to the election of Michael Sen as its chair.

“Our shareholders’ vote today clearly is a sign of confidence showing that we are on the right track with Fresenius and with Fresenius Medical Care,” Sen said. “As the Chair o…

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Fresenius Medical Care appoints new CFO

New Fresenius Medical Care CFO Martin Fischer. [Image from Martin Fischer on LinkedIn]Fresenius Medical Care announced today that it appointed Martin Fischer as its new chief financial officer (CFO).

Fischer’s appointment goes into effect on Oct. 1, 2023. He succeeds Helen Giza, who took over as CEO and board chair in December 2022. She took on the corner office after CEO Carla Kriwet decided to leave the company “at her own request and by mutual agreement due to strategic differences.” Giza continued to serve as acting CFO over the past seven months.

“Martin Fischer has proven that he can successfully drive fundamental change in organizations,” Giza said in a news release. “In our organizational transformation and turnaround management, we will benefit from his finance and healthcare expertise. Martin will be an important contributor to the execution of our strategy in unlocking value as the leading kidney care company.”


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Fresenius Medical Care joins health equity pledge

Fresenius Medical Care announced today that it joined the Zero Health Gaps Pledge at the World Economic Forum in Davos, Switzerland.

As part of the Global Health Equity Network (GHEN), the pledge brings together stakeholders from the public and private sectors. In line with the UN Sustainable Development Goals, they aim to advance a collective vision of “Zero Health Gaps,” making improvements in health equity.

In total, 39 organizations joined the pledge. Medtronic announced yesterday that it took part. Other medtech companies joining include Henry Schein, Hologic and Philips, according to the World Economic Forum.

Fresenius said its involvement marks a commitment to “meaningful action and collaboration toward health equity.”

“We believe that access to equitable and high-quality health care is a fundamental human right, and we are committed to working with global leaders and organizations to improve the lives of millions of…

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The biggest medtech personnel moves in 2022

Some of the largest companies in medtech have promoted, replaced or removed leaders in recent months.

In July, Medical Design & Outsourcing compiled a list of the biggest personnel changes in the first half of 2022. Those included hirings, firings, promotions and  retirements of CEOs, presidents and and other business leaders across the medtech industry.

The latter half of the year has brought even more changes. To close out 2022 and prepare for 2023, here are more of the year’s biggest medtech moves — and some updates since the news first broke.

Butterfly Network CEO steps down

Todd Fruchterman

On Dec. 6, Butterfly Network (NYSE:BFLY) announced that it reached a mutual agreement with Dr. Todd Fuchterman to step down as president and CEO. Fruchterman also left Butterfly’s board of directors.

Fruchterman oversaw Butterfly’s development of artificial intelligence-based ha…

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Fresenius Medical Care’s CEO leaves after two months in top spot

Carla Kriwet [Photo courtesy of Fresenius]Fresenius said Fresenius Medical Care (NYSE:FMS) CEO Carla Kriwet will leave the company “at her own request and by mutual agreement due to strategic differences.”

The Bad Homburg, Germany-based dialysis provider instead named Deputy CEO and CFO Helen Giza as the division’s next CEO.

When announcing Kriwet’s promotion and Giza’s new role of deputy CEO in May, Fresenius said it would enter into a new 5-year employment contract with Giza. Kriwet was set to replace longtime CEO Rice Powell on Jan. 1, 2023, with him stepping down as CEO of Fresenius Medical Care on Dec. 31 after hitting the company’s age limit.

But Kriwet took over on Oct. 1 with Giza assuming “certain functions of the role of chief executive officer for a brief interim period,” the company said in SEC filings on Oct. 31.

That same month, the company said it expected net income for the year to decline at …

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FDA clears heat purification, remote therapy from Fresenius

Fresenius Medical Care North America (FMCNA) recently announced FDA clearances for two of its technologies used in dialysis care.

Today, the Waltham, Massachusetts-based company announced FDA clearance for the AquaA water system. The company designed it as a water purification system for hemodialysis.

Yesterday, the FDA granted 510(k) clearance to upgrade Fresenius’ Liberty Select cycler. Clearance enables remote therapy with the Kinexus therapy management platform. It aims to elevate the home therapy experience for peritoneal dialysis (PD) patients and clinicians.

AquaA uses advanced technology to optimize water and power usage with full heat disinfection. It offers customization capabilities for the unique needs of each dialysis center. AquaA uses reverse osmosis (RO) to remove organic and inorganic substances and microbial contaminants from the water. Its intelligent technology and resource-efficient design provide low maintenance requirements a…

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Fresenius Medical Care designs quick-change dialysis filter

The Fresenius Medical Care Cartridge Express with Speedswap [Image courtesy of Fresenius Medical Care]

Fresenius Medical Care North America’s Renal Therapies Group has a new way to quickly change a flow-compromised dialysis filter without replacing the entire cartridge.

The dialysis provider and equipment manufacturer said today that its new Speedswap system is designed to address the common clogging or clotting of the dialysis circuit in continuous kidney replacement therapy (CKRT) in critical care settings. Speedswap is meant to shorten the time needed to change dialysis filters, reducing therapy downtime, easing nurse workloads and lowering treatment costs.

“This introduction of Speedswap aims to both improve the quality of dialysis treatment in the critical care setting and make our technology even easier to use by the care team,” Renal Therapies Group President Joe Turk said in a n…

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Fresenius’ NxStage launches Speedswap for critical care dialysis

Fresenius Medical Care North America’s renal therapies group announced today that it launched the Speedswap for the NxStage System One with NxView.

Speedswap, a new option for the NxStage System One with NxView, enables the changing of a flow-compromised dialysis filter without replacing the entire cartridge.

According to a news release, Fresenius designed the new Speedswap system to help reduce therapy downtime, ease nursing workloads and lower treatment costs in acute care settings by improving the filter change through the use of a pre-attached, yet detachable, filter that allows for the replacement without replacing a cartridge.

“This introduction of Speedswap aims to both improve the quality of dialysis treatment in the critical care setting and make our technology even easier to use by the care team,” said Joe Turk, president of the Renal Therapies Group at Fresenius Medical Care North America. “This product is another examp…

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