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 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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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 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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The biggest medtech personnel moves so far in 2022

In the ever-changing world of medtech, those who are leading the companies are bound to move around a bit.

At the end of last year, we compiled a list of medtech’s biggest personnel changes in 2021. Throughout just over half of 2022, we’ve already seen a slew of major moves around some of the space’s most powerful players.

Here is a list of some of the biggest personnel changes in medtech so far in 2022:

3M’s healthcare president retires 3M Health Care Business Group President Mojdeh Poul [Image courtesy of 3M]Mojdeh Poul, the president of 3M’s healthcare business, announced in May that she would retire from the position and her retirement was made effective on July 1.

Poul joined 3M in 2011 as the global business VP of critical and chronic care solutions. She later became VP and general manager of the company’s food safety business and president of numerous 3M divisions, including infection prevention, 3M Canada, and sa…

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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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Fresenius Kabi to acquire Ivenix and its smart infusion system for $240M upfront

Fresenius Kabi announced today that it will acquire Ivenix with plans to bring a comprehensive infusion product portfolio to the U.S.

The acquisition, which has a purchase price of $240 million upfront, also includes potential milestone payments linked to achievements of commercial and operating targets.

Get the full story at our sister site, Drug Delivery Business News.

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Fresenius enters 3-way merger to create independent kidney care provider

Fresenius Medical Care announced today that it entered into an agreement to create a new company for providing kidney care.

The agreement combines Fresenius Medical Care North America’s value-based care division, Fresenius Health Partners, with InterWell Health and Cricket Health.

Both InterWell and Cricket represent U.S.-based kidney care providers, with Interwell a leading physician organization within the space and Cricket offering value-based kidney care with a patient engagement and data platform, according to a news release.

The merger combines Fresenius Health Partners’ kidney care expertise with InterWell’s clinical care models and network of 1,600 nephrologists and Cricket’s tech-enabled care model that uses its proprietary StageSmart informatics and patient engagement platforms.

Valued at $2.4 billion, the new company — which will be fully consolidated by Fresenius Medical Care as the majority owner — will operate…

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Siemens Healthineers executive to join Fresenius supervisory board

Dr. Christoph Zindel, Siemens Healthineers [Image courtesy of Siemens Healthineers]Fresenius SE & Co. KGaA announced today that it plans for Siemens Healthineers executive Dr. Christoph Zindel to join its Supervisory Board.

Zindel will stand for election at Fresenius’ Annual General Meeting on May 13.

A member of Siemens Healthineer’s managing board, Zindel’s responsibilities at the German medtech giant include imaging, advanced therapies, technology excellence, quality and regulatory, the Healthineers Performance System, and sustainability.

Zindel will replace Klaus-Peter Müller, 77, who has been on the Supervisory Board and its Audit Committee since 2008.


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Fresenius Medical Care earns ‘B’ rating for climate protection measures

Fresenius Medical Care announced today that it received a positive rating for its efforts in climate protection.

According to a news release, the company garnered a “B” rating from the nonprofit organization CDP, marking its place in the second-highest categories.

Fresenius said it received a “B” in the climate area and a “B-” in the water area. The company said the rating solidifies its place as one of the leading companies in the healthcare sector with regard to climate protection measures.

Companies listed in “A” and “B” categories are characterized by transparency, coordinated climate protection measures and the implementation of corresponding best-practice approaches.

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