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Fresenius

FDA clears software for Fresenius home hemodialysis system

August 23, 2023 By Sean Whooley

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 […]

Filed Under: 510(k), Dialysis, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT Tagged With: Fresenius, Fresenius Medical Care

Fresenius Medical Care stock dips on mixed Q2 results

August 2, 2023 By Sean Whooley

Fresenius Medical Care 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 […]

Filed Under: Business/Financial News, Dialysis, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Fresenius, Fresenius Medical Care

Fresenius Medical Care joins health equity pledge

January 20, 2023 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Dialysis, Healthcare Reform, News Well Tagged With: Fresenius, Fresenius Medical Care, Henry Schein, Hologic, Medtronic, Philips

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

December 6, 2022 By Jim Hammerand

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 […]

Filed Under: Business/Financial News, Dialysis, Featured, News Well Tagged With: Fresenius, Fresenius Medical Care, Personnel Moves

FDA clears heat purification, remote therapy from Fresenius

November 3, 2022 By Sean Whooley

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. […]

Filed Under: Blood Management, Business/Financial News, Dialysis, Featured, News Well Tagged With: Fresenius, Fresenius Medical Care

Fresenius Medical Care reports labor issues, inflation challenges as it cuts 2022 outlook

August 2, 2022 By Sean Whooley

Fresenius Medical Care (NYSE:FMS) shares are up slightly 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% […]

Filed Under: Blood Management, Business/Financial News, Dialysis, Featured, MassDevice Earnings Roundup, News Well, Wall Street Beat Tagged With: Fresenius, Fresenius Medical Care

The biggest medtech personnel moves so far in 2022

July 22, 2022 By Sean Whooley

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. So far in 2022, we’ve already seen a slew of major moves involving some of the space’s most powerful […]

Filed Under: Business/Financial News, Featured Tagged With: 3m, Acutus Medical, Ambu, augmedics, Bausch + Lomb, BD, Better Therapeutics, Boston Scientific, Cardiovascular Systems, dentsply, Dentsply Sirona, Fresenius, Globus Medical, HeartFlow, Henry Schein, Insulet, Johnson & Johnson, Johnson & Johnson MedTech, Medtronic, Merit Medical Systems, Personnel Moves, Philips, Smith+Nephew, Titan Medical Inc.

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

April 21, 2022 By Sean Whooley

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 […]

Filed Under: 510(k), Business/Financial News, Dialysis, Featured, Food & Drug Administration (FDA), News Well, Patient Monitoring, Regulatory/Compliance Tagged With: FDA, Fresenius, Fresenius Medical Care

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

March 31, 2022 By Sean Whooley

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.

Filed Under: Business/Financial News, Drug Pumps, Drug-Device Combinations, Featured, Mergers & Acquisitions, News Well, Pharmaceutical Tagged With: Fresenius, Fresenius Kabi, Ivenix

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

March 21, 2022 By Sean Whooley

Fresenius Medical Care announced today that it 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. Both InterWell and Cricket represent U.S.-based kidney care providers, with Interwell […]

Filed Under: Business/Financial News, Dialysis, Featured, Mergers & Acquisitions, News Well Tagged With: Cricket Health, Fresenius, Fresenius Medical Care, InterWell

Siemens Healthineers executive to join Fresenius supervisory board

March 18, 2022 By Chris Newmarker

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, […]

Filed Under: Business/Financial News Tagged With: Fresenius, Personnel Moves, Siemens Healthineers

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