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Avenu Medical wins CMS reimbursement for Ellipsys dialysis device
Vascular access system maker Avenu Medical said last Friday it won a HCPCS C-Code from the Centers for Medicare and Medicaid Services for its Ellipsys dialysis device and the endoAVF procedure. The San Juan Capistrano, Calif.-based company’s Ellipsys vascular access system device is designed for use with end-stage renal disease patients who require hemodialysis. The system, which can be used under local or regional anesthesia, uses an ultrasound-guided catheter that delivers a small amount of thermal energy to fuse a permanent anastomosis between the vein and artery to create an AVF. The newly granted HCPCS reimbur...
Source: Mass Device - November 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Vascular Avenu Medical Source Type: news

Fresenius Medical Care to Pay $231 Mln to Resolve Criminal, Civil Foreign Bribery Charges Fresenius Medical Care to Pay $231 Mln to Resolve Criminal, Civil Foreign Bribery Charges
Germany-based dialysis clinic operator Fresenius Medical Care AG will pay about $231 million to resolve criminal and civil allegations that the company paid bribes to public health and government officials in several countries to win or retain business, the U.S. Justice Department said on Friday.Reuters Health Information
Source: Medscape Medical News Headlines - April 1, 2019 Category: Consumer Health News Tags: Family Medicine/Primary Care News Source Type: news

Age is not a risk factor in survival of severely ill patients with co-morbidities in a medical intensive care unit
ConclusionAge and gender were not found to be predictors of mortality. There was no survival advantage between young and elderly patients. Co-morbid diseases, apart from malignancy, had no effect on mortality. In developing countries, where patients with terminal illness and multiple co-morbid diseases are treated in the ICU, age should not be a determining factor in patient selection for ICU or in the treatment decisions to be applied to patients.
Source: Irish Journal of Medical Science - July 3, 2020 Category: General Medicine Source Type: research

How to assess the risks associated with the usage of a medical device based on predictive modeling: the case of an anemia control model certified as medical device
CONCLUSIONS: The risks of an ACM-MD can be accurately and robustly estimated, thus enhancing patients' safety. The proposed methodology is applicable to other clinical decisions based on predictive models since our proposal does not depend on the particular predictive model.PMID:34612120 | DOI:10.1080/17434440.2021.1990037
Source: Expert Review of Medical Devices - October 6, 2021 Category: Medical Devices Authors: Carlo Barbieri Luca Neri Milena Chermisi Elena Bolzoni Isabella Cattinelli Wolfgang Decker Jos é D Martín-Guerrero Flavio Mari Source Type: research

Fine-tuned continuous renal replacement therapy with calcium-free dialysate to manage severe hypercalcemia refractory to medical and intermittent hemodialysis
AbstractMalignancy-related hypercalcemia is a leading cause of hypercalcemia among hospitalized patients that carries poor prognosis. Parathyroid carcinoma is a rare form of primary hyperparathyroidism that may be associated with PTH dependent hypercalcemia. Severe hypercalcemia is life-threatening and may require management in an intensive care unit by means of medical therapy consisting of volume expansion, loop diuretics, cinacalcet, calcitonin and bisphosphonates. Renal replacement therapy such as intermittent hemodialysis has been successfully used among patients with severe hypercalcemia who become refractory to medi...
Source: European Journal of Medical Research - June 8, 2022 Category: Research Source Type: research

WetAlert Wireless Wetness Detector From Fresenius Medical Care
Fresenius Medical Care, the world's largest provider of dialysis products and services, announced recently its introduction of the WetAlert wireless wetness detector, designed to detect venous needle displacement and prevent blood loss for dialysis patients at home
Source: Medical Design Online News - February 12, 2013 Category: Medical Equipment Source Type: news

Fresenius Medical Care Acquires Cogent Healthcare
Fresenius Medical Care (FMC), the world’s largest provider of dialysis products and services, recently acquired hospitalist group Cogent Healthcare through its subsidiary Sound Inpatient Physicians. The transaction, which will create the largest private provider of hospitalist and intensivist services, is expected to be completed by the end of the quarter.
Source: Medical Design Online News - November 18, 2014 Category: Medical Equipment Source Type: news

Outset Medical Announces $91 Million in New Funding for First-Of-Its-Kind FDA-Cleared Dialysis Technology
Outset Medical, a company focused on reimagining the experience of dialysis care for patients with kidney disease, today announced $91 million in equity and debt funding. New investor Fidelity Research and Management Company led the $51 million equity financing, with participation from existing investors Warburg Pincus and The Vertical Group, as well as new investors Partner Fund Management LP, Perceptive Advisors and CRG. In addition, CRG led a $40 million debt financing. This Smart
Source: Medical Design Online News - June 9, 2015 Category: Medical Equipment Source Type: news

Outset Medical Announces $91 Million In New Funding For First-Of-Its-Kind FDA-Cleared Dialysis Technology
Outset Medical, a company focused on reimagining the experience of dialysis care for patients with kidney disease, today announced $91 million in equity and debt funding. New investor Fidelity Research and Management Company led the $51 million equity financing, with participation from existing investors Warburg Pincus and The Vertical Group, as well as new investors Partner Fund Management LP, Perceptive Advisors and CRG. In addition, CRG led a $40 million debt financing. This Smart
Source: Medical Design Online News - June 9, 2015 Category: Medical Equipment Source Type: news

Yelp adds health care statistics to medical business listings
Crowdsourced business review website Yelp has partnered with non-profit newsroom ProPublica to add more healthcare statistics to Yelp’s 25,000 medical treatment facility business pages. With this new offering, Yelp will provide customers access to information about hospitals, nursing homes, and dialysis clinics that could help them make more informed decisions about a hospital for a sick child or a nursing […]
Source: mobihealthnews - August 6, 2015 Category: Information Technology Authors: Aditi Pai Tags: Consumer Uncategorized health facility ratings hospital ratings medical facility ratings ProPublica Yelp Source Type: news

CryoLife deals Hero graft to Merit Medical for $19m
CryoLife Inc. (NYSE:CRY) said today that it dealt its Hero hemodialysis access graft to Merit Medical (NSDQ:MMSI) for $18.5 million in cash. The Hero graft put up $7.5 million in sales for CryoLife last year, the Atlanta-based company said. The deal calls for CryoLife to continue manufacturing the device for up to 6 months, when Salt Lake City-based Merit will take over production. “The recent acquisition of On-X Life Technologies strengthened our strategic focus on aortic and mitral valve repair and replacement surgery. The transaction more than doubled our U.S. cardiac surgery sales force. The sale of the Hero gr...
Source: Mass Device - February 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Dialysis Mergers & Acquisitions Wall Street Beat CryoLife Merit Medical Systems Inc. Source Type: news

Exthera Medical closes $12 million Series A for Seraph blood infection filter
Martinez, Calif.-based Exthera Medical said it raised a $12 million Series A round following positive tests of its CE-Marked Seraph  blood filter in animal studies. The company announced in January that was selected for participation in a subcontract with the U.S. Defense Advanced Research Projects Agency due to results showing the safety and efficacy of the Seraph device. The device removed an average of 80% of methicillin-resistant Staphylococcus aureus bacteria, the company said. Following the Seraph’s CE Marking for a clinical trial in December 2015, chief technology officer Keith McCrea said the company ...
Source: Mass Device - May 13, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Blood Management Funding Roundup ExThera Medical Source Type: news

Case Report of Kidney Paired Donation (KPD) with Desensitization: the Strategy and Experience of 3-Way KPD in Samsung Medical Center.
Authors: Oh D, Kang ES, Yu S, Chun K, Huh W, Jang HR, Cho CW, Lee N, Lee KW, Park H, Park JB, Kim SJ Abstract As the need for the organ donation increases, strategies to increase kidney transplantation (KT) through expanded living donation have become essential. These include kidney paired donation (KPD) programs and desensitization in incompatible transplantations. KPD enables kidney transplant candidates with incompatible living donors to join a registry with other incompatible pairs in order to find potentially compatible living donor. Positive cross match and ABO incompatible transplantation has been successful...
Source: Journal of Korean Medical Science - January 21, 2018 Category: Biomedical Science Tags: J Korean Med Sci Source Type: research

NxStage Medical, Fresenius again delay $2B merger
NxStage Medical (NSDQ:NXTM) yesterday once more delayed its pending $2 billion merger with Fresenius (NYSE:FMS) as the U.S. Federal Trade Commission continues to examine the deal. In July, the German renal care giant and Lawrence, Mass.-based NxStage extended the deal’s closing date by 90 days, from August 7 to Nov. 5, saying it still expected to close the deal this year. Yesterday, in a regulatory filing with the U.S. Securities & Exchange Commission, NxStage said the companies agreed this week to push the target back another thee months, to Feb. 5, 2019. For its part, Fresenius said it still expects to cl...
Source: Mass Device - October 31, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Dialysis Featured Mergers & Acquisitions Wall Street Beat Anti-Trust Fresenius NxStage Medical Inc. Source Type: news