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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Fresenius Medical Care spins its Health Partners business into three-way merger

Fresenius Medical Care announced today that the three-way merger it announced earlier this year has closed.

In March, Fresenius entered into an agreement to create a new company for providing kidney care. The agreement involves Fresenius Health Partners (Fresenius Medical Care North America’s value-based care division) entering into a combination with InterWell Health and Cricket Health.

According to a news release, the three-way merger has today officially satisfied customary closing conditions and received regulatory clearance in the U.S.

The new company will operate under the InterWell Health brand, bringing Fresenius Health Partners’ expertise in kidney care together with InterWell’s clinical care models and Cricket Health’s tech-enabled care model that utilizes StageSmart informatics and patient engagement platforms. Altogether, Fresenius said this creates “an innovative, stand-alone entity poised to transform kidney care.…

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Fresenius Medical Care beats Street in Q2, cuts 2022 outlook

Fresenius Medical Care (NYSE:FMS) shares rose today on second-quarter results that topped the consensus forecast.

The Bad Homburg v. d. Höhe, Germany-based dialysis company posted profits of $150.3 million (€147 million), or 51¢ (€0.50) per share, on sales of $4.9 (€4.75 billion) billion for the three months ended June 30, 2022, for a 32.9% bottom-line slide on sales growth of 10.1%.

Adjusted to exclude one-time items, earnings per share were 78¢ (€0.77), 34¢ ahead of Wall Street, where analysts were looking for sales of $4.7 billion.

Headwinds from labor issues and inflation harmed the company’s results, according to a news release, with “meaningfully higher than assumed wage inflation, surcharges, retention payments and additional costs for contract labor to contain the increasing staff shortages.”

The company said that, despite additional investments in labor, staff shortages and turnover rates remain on the rise, affecting se…

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What Fresenius learned about COVID, kidneys and dialysis in the pandemic

Dr. Robert Kossmann is the chief medical officer for Fresenius Medical Care North America [Photo courtesy of Fresenius]

Dr. Robert Kossmann has a unique perspective of kidney care as the chief medical officer for Fresenius Medical Care North America and head of renal therapies for the company’s global medical office.

Germany-based Fresenius is the world’s largest provider of dialysis equipment and dialysis services, offering treatments at traditional dialysis centers as well as in patients’ homes.

Medical Design & Outsourcing recently spoke with Kossmann about kidney care in the pandemic, the challenges and benefits of home dialysis, logistics lessons learned and growth opportunities that medtech designers and engineers should keep in mind.

This conversation has been lightly edited for space and clarity.

MDO: What does COVID do to the kidneys during and after an infect…

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DOJ files fraud suit against Fresenius Medical division

Federal attorneys accused Fresenius Medical Care’s vascular care unit of performing unnecessary procedures on dialysis patients and billing the federal government.

U.S. Attorney for the Eastern District of New York Breon Peace made the allegations yesterday against Fresenius Vascular Care — doing business as Azura Vascular Care — as part of a whistleblower suit filed by two doctors in 2014.

Bad Homburg, Germany-based parent company Fresenius Medical Care said it disputes the allegations and intends to mount a vigorous defense.

“Our network of vascular centers is leading efforts to reduce total healthcare costs and improve patient outcomes by expanding access to innovative and less-invasive procedures,” the company said in a statement sent to Medical Design & Outsourcing. “Our policies are intended to result in a high standard of care and compliance with government regulations.”

Prosecutors said Azura Vascular Care…

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FDA warns of potential toxic risk from Fresenius hemodialysis machines

The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines.

The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K.

The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) — are in the silicone tubing used in the dialysate lines and the machine’s hydraulics.

“Although this silicone tubing does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment,” the FDA said in a May 6 letter to health care providers.

Get the full story at our sister site, Medical Design & Outsourcing.

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FDA warns of potential toxic risk from Fresenius hemodialysis machines

The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines.

The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K.

The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) — are in the silicone tubing used in the dialysate lines and the machine’s hydraulics.

“Although this silicone tubing does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment,” the FDA said in a May 6 letter to health care providers.

The FDA said it has not received any related reports of adverse events, but said the chemicals in animals have been linked to endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.

Fresen…

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Fresenius Medical Care hires replacement for longtime CEO

Carla Kriwet will become CEO of Fresenius Medical Care [Photo courtesy of Fresenius]Fresenius Medical Care (NYSE: FMS) has hired Carla Kriwet as its next CEO effective Jan. 1, 2023.

Kriwet will replace Rice Powell, who will step down on Dec. 31 after hitting the company’s age limit. Powell is 66. Kriwet is 51.

“I fully identify with the vision of making the lives of the patients who have put their trust in us a little more worth living every day,” Kriwet said in a news release yesterday. “And I’m convinced that bringing ever better medicine to ever more people goes hand in hand with economic success.”

Get the full story at our sister site, Medical Design & Outsourcing.

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Fresenius Medical Care hires replacement for longtime CEO

Carla Kriwet will become CEO of Fresenius Medical Care [Photo courtesy of Fresenius]

Fresenius Medical Care (NYSE: FMS) has hired Carla Kriwet as its next CEO effective Jan. 1, 2023.

Kriwet will replace Rice Powell, who will step down on Dec. 31 after hitting the company’s age limit. Powell is 66. Kriwet is 51.

“I fully identify with the vision of making the lives of the patients who have put their trust in us a little more worth living every day,” Kriwet said in a news release yesterday. “And I’m convinced that bringing ever better medicine to ever more people goes hand in hand with economic success.”

Fresenius CFO and CTO Helen Giza will assume the position of deputy CEO and enter into a new 5-year employment contract, the company said.

Kriwet served as CEO and president of BSH Hausgeräte (Home Appliances) GmbH from July 2020 until she stepped down for her ne…

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

[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 pa…

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