Simergent announced plans to use a new round of seed money, $2.835 million, to further development of a cheaper, quieter home dialysis machine. The company, with offices in Oklahoma City and Chicago, said in a media release that its Archimedes dialysis system “aims to reduce healthcare expenditures, improve patient health, and make it easier for patients to perform dialysis at home.”
The majority of funding for this innovation comes from the Oklahoma-based company i2E. The funding will support Simergent as it continues to design the system, manufacture the device, and perform regulatory testing needed for FDA approval.
The US Food and Drug Administration (FDA) has approved a new stent for use in the treatment of kidney failure patients who are on hemodialysis.
Bard, now a part of healthcare tech giant Becton Dickinson (Franklin Lakes, NJ) was the originator of the Covera vascular covered stent. The stent, which is used to re-open narrowed access circuits in an arteriovenous fistula, has a “helical design for radial strength and flexibility” and an “atraumatic” tip for insertion comfort, according to CRBard.com. According to Becton Dickinson, it is the first and only covered stent to be approved in the US
Abbott Laboratories (Chicago, IL) currently leads the market in pain-free glucose monitoring, Crain’s Chicago Business reports. Abbott offers the FreeStyle Libre, which measures glucose via a sensor without fingersticks. According to Crain’s, Abbott’s device has more than 1.3 million users worldwide and posted 37% sales growth to $1.9 billion in 2018.
Dexcom (San Diego, CA) and Medtronic (Minneapolis, MN) also offer pain-free monitors. The latest Dexcom device, the G6 CGM, warns users of an urgently low or high level of glucose minutes before it hits. Data can also be shared with others through smart devices, for example, with parents who
Rural dialysis does not pay as well as dialysis in urban facilities, according to a recent report from the Medicare Payment Advisory Commission (MedPAC).
The March 2019 report noted that facilities with high volumes of dialysis earned higher margins because cost per treatment falls with efficiencies, and that urban facilities had higher financial margins (-0.4%) than do rural facilities (–5.5%).
Treatment volume accounted for most of the differential in margins between urban and rural facilities. In 2017, urban facilities averaged about 12,000 treatments, while rural facilities each performed about 7800 treatments. A “low-volume facility” is defined as one that provides
Roche and IBM have teamed up to parse half a million electronic health records (EHRs) to create a predictive algorithm for patients with early risk of chronic kidney disease (CKD) related to diabetes. The industry duo developed the algorithm based on real-world data.
Age, body mass index, and glomerular filtration rate as well as concentrations of creatinine, albumin, glucose, and hemoglobin (HbA1c) were selected as important predictors on the basis of “a data-driven and medical selection for the study,” according to the paper, published in Nature Medicine (1). CKD was defined as a microvascular long-term complication
The world is one step closer to a dialysis device that can be readily carried by a patient, while another company is working to create an ultra-thin blood filter for a wearable dialysis device.
The US FDA has granted a Breakthrough Device designation to AWAK Technologies (Singapore) for a new peritoneal dialysis (PD) device, the AWAK PD.
The device is a wearable, portable PD system that incorporates AWAK’s sorbent technology. It weighs less than 2 kg, and 6 to 8 hours of therapy provide 12–16 L of total dialysate flow. The machine is small enough that it may be carried
AstraZeneca (Cambridge, UK) is emphasizing its dedication to chronic kidney disease (CKD) and related conditions. In a sign of its focus on the “R” in its renamed division, Cardiovascular, Renal, and Metabolism (CVRM), the company offered research and information in 35 separate scientific articles and data presentations during Kidney Week 2018.
Formerly known as CVMD (cardiovascular, renal, and metabolic diseases), the division was renamed in early 2018. Renal work has become an urgent area of concern, said Elisabeth Bjork, vice president of CVRM for Global Medicines Development. “Deaths due to CKD specifically more than doubled between 1990 and 2013,” she
HealthCare Partners Holdings LLC, part of DaVita Inc., must pay $270 million to settle an allegation involving Medicare Advantage insurance plans.
According to a news release from the U.S. Department of Justice, DaVita Medical Holdings agreed to pay the money to resolve its liability under the False Claims Act. The Justice Department reported that HealthCare Partners provided “inaccurate information that caused Medicare Advantage Plans to receive inflated Medicare payments.”
Medicare beneficiaries have the option of enrolling in and obtaining health care from Medicare Advantage Plans that are owned and operated by private Medicare Advantage Organizations (MAOs). To provide the patient
Two companies have been given the thumbs-up by the U.S. Food and Drug Administration (FDA) for kidney-related therapies. Hansa Medical (Lund, Sweden) has been granted FDA Fast Track Designation for its drug candidate imlifidase to help reduce kidney rejection in transplantation. Under this designation, the FDA process is designed to facilitate development and expedite the review of drugs that could treat serious conditions and fill an unmet medical need. Another company, MediBeacon Inc. (St. Louis, MO) has been granted a Breakthrough Designation for its transdermal measurement device for GFR, a designation given when a product may show improvement over available
A new study called FirstX is now enrolling participants and will examine a compound called CXA-10 in primary FSGS as a first-line drug for people who would normally have been treated with high-dose steroids. CXA-10 is in a class of oral compounds called nitrated fatty acids. It is a signaling agent with anti-inflammatory/immunomodulatory, antifibrotic, antioxidative, and other properties that are important in the pathobiology of FSGS, according to an abstract for the trial presented during ASN Kidney Week 2018.
Primary FSGS is often treated with steroids, but side effects of prolonged use may include obesity, hypertension, growth impairment, diabetes, and